Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012314549

FEI Number

3012314549

Entity Name

NINGBO TIANBO FIRST AID PRODUCT CO., LTD.

City/State/Country

Ningbo Zhejiang, CN

Establishment Address

Yushantou village,Dongqiao Town,Haishu, Ningbo Zhejiang 315000, CN

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

NINGBO TIANBO FIRST AID PRODUCT CO., LTD. (Owner Number: 10050491)

Owner / Operator Contact Address

Yushantou village,Dongqiao Town,Haishu, Ningbo, CN-ZJ 315000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K121992

PMA Number

N/A

All Registered Proprietary Names

disposable face mask, surgical caps, hoods, gowns, isolation masks,Multifunction knife, Knife,Scissors thermometer, clinical mercury oropharyngeal airway,nasopharyngeal airway Finger cot emergency light stick Mask, surgical FACE MASK,breath Mask Garment incontinence blanket,EMERGENCY BLANKET DEPRESSOR, TONGUE, NON-SURGICAL BURN DRESSING, BURN GEL, BURN RELIVE Elastic Bandage, Gauze Elastomer SILICONE Face mask poison remover; suction pads, menstrual, scented-deodorized COLD PACK,HOT OR COLD PAD,insant cold pad SYRINGE, IRRIGATING (NON DENTAL) Tweezers, Tick Remover strip,temperature,Forehead,liqiud crystal thermometer CPR mask crank flashlight, multifucntion torch blood collection cotton/ cotton roll,medical absorbent fiber TISSUE, PAPER TISSUE, paper facial tissue,toilet tissue facial tissues SPLINT ,HARD AND COMPONENTS CPR shield; Mask, Oxygen COTTON TIPPED/ABSORBENT TIPPED PVC GLOVES SAFETY PINS emergency whistle Paracord Bracelet, Warning Vest, Reflective Jacket cervical collar,cervical gear,collar support,neck collar,neck splint,neck brace SCISSORS, MEDICAL, DISPOSABLE poison remover water purification Anti-inflammatory gel, Anti-inflammatory cream, Disinfectant gel, Disinfectant cream, Cleaning Wipe Disinfectant, BZK PAD, Alcohol Pad, Sting Relief, Sanitizer , Hand Sanitizer, Antiseptic Towelette Inhaler,NASAL,VAPOR INHALER Adhesive Tape; Band-Aid, Adhesive Bandage,SLING ARM,triangular gauze bandage,Gauze Bandage Conforming Elastic Bandages, Crepe Bandages DISPOSABLE PVC GLOVES, Disposable nitrile gloves, Vinyl gloves and PE gloves CorDx @AL21 First aid kit First Aid Kit With Drug Tourniquet, Nonpneumatic,CAT Tourniquet reminder pill box Eye washing solution; Skin washing solution Eye washing solution; Skin washing solution; shampoo; Shower gel; soap anesthetic gas mask Eye pad Gauze pad; Gauze sponge,STERILE AND NON-STERILE DRESSING; STERILE AND NON-STERILE PADS raincoat lumbar support,lumbar belt,lumbar fixation,waistband stretcher Shield, Vial - SHIELD,VIAL, SAFETY GOGGLES Safety Pin, Pins, Assorted Pins nitrile examination glove

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2015-11-23
FLK	Thermometer, Clinical Mercury	General Hospital	Class 2	880.2920	2015-11-23
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	Class 1	868.5110	2015-11-23
LZB	Finger Cot	General Hospital	Class 1	880.6250	2025-08-05
KDC	Instrument, Surgical, Disposable	General, Plastic Surgery	Class 1	878.4800	2015-11-24
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2025-03-20
KHA	Mask, Scavenging	Anesthesiology	Class 1	868.5590	2015-11-23
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2015-11-23
FMA	Depressor, Tongue, Non-Surgical	General Hospital	Class 1	880.6230	2022-05-19
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2015-11-24
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2015-11-23
MDA	Elastomer, Silicone, For Scar Management	General, Plastic Surgery	Class 1	878.4025	2015-11-23
QKR	Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua	Unknown	Class N	N/A	2021-07-29
GCY	Apparatus, Suction, Single Patient Use, Portable, Nonpowered	General, Plastic Surgery	Class 1	878.4680	2021-05-17
NRC	Pad, Menstrual, Scented, Scented-Deodorized Made Of Common Cellulosic & Synthetic Material W/Established Safety Profile	Obstetrics/Gynecology	Class 1	884.5425	2015-11-23
KYR	Bag, Ice	General Hospital	Class 1	880.6050	2015-11-23
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2025-07-01
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2015-11-23
KPD	Strip, Temperature, Forehead, Liquid Crystal	General Hospital	Class 2	880.2200	2015-11-23
FQZ	Thermometer, Clinical Color Change	General Hospital	Class 1	880.2900	2024-08-08
BYP	Mouthpiece, Breathing	Anesthesiology	Class 1	868.5620	2015-11-23
KYT	Light, Examination, Medical, Battery Powered	General Hospital	Class 1	880.6350	2015-11-24
KST	System, Blood Collection, Vacuum-Assisted, Manual	Hematology	Class 1	864.9125	2015-11-24
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2015-11-23
DMG	Papers, Ion	Clinical Chemistry	Class 1	862.2230	2016-11-15
KHR	Absorber, Saliva, Paper	Dental	Class 1	872.6050	2015-11-24
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2015-11-24
KGB	Mask, Oxygen, Non-Rebreathing	Anesthesiology	Class 1	868.5570	2015-11-23
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2015-11-24
LYZ	Vinyl Patient Examination Glove	General Hospital	Class 1	880.6250	2025-07-01
GFC	Driver, Surgical, Pin	General, Plastic Surgery	Class 1	878.4820	2015-11-23
MNL	Accessories, Cleaning Brushes, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2015-11-24
IKX	Aid, Transfer	Physical Medicine	Class 1	890.5050	2015-11-24
IQF	Orthosis, Cervical-Thoracic, Rigid	Physical Medicine	Class 1	890.3490	2016-01-23
JOK	Scissors, Medical, Disposable	General Hospital	Class 1	880.6820	2023-05-18
NJZ	Extractor, Vein	General, Plastic Surgery	Class 1	878.4800	2018-11-21
LRJ	Disinfectant, Medical Devices	General Hospital	Class 1	880.6890	2015-11-23
KCO	Nasal Spray, Ent Delivery	Ear, Nose, Throat	Class 1	874.5220	2015-11-24
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2015-11-23
JTM	Anaerobic Box Glove	Microbiology	Class 1	866.2120	2015-11-24
LRR	First Aid Kit With Drug	Unknown	Class N	N/A	2015-11-24
GAX	Tourniquet, Nonpneumatic	General, Plastic Surgery	Class 1	878.5900	2015-11-23
NXQ	Reminder, Medication	Physical Medicine	Class 1	890.5050	2015-11-23
JCE	Solution, Isotonic	Pathology	Class 1	864.4010	2015-11-24
BSJ	Mask, Gas, Anesthetic	Anesthesiology	Class 1	868.5550	2015-11-23
HMP	Pad, Eye	General, Plastic Surgery	Class 1	878.4440	2015-11-23
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2015-11-23
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2018-11-21
IQE	Orthosis, Lumbar	Physical Medicine	Class 1	890.3490	2016-01-23
FPP	Stretcher, Hand-Carried	General Hospital	Class 1	880.6900	2018-11-21
IWW	Shield, Vial	Radiology	Class 1	892.6500	2015-11-23
HXQ	Crimper, Pin	Orthopedic	Class 1	888.4540	2016-11-15
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2025-07-01

Official Correspondent

Xiancheng Jiang

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

NINGBO TIANBO FIRST AID PRODUCT CO., LTD.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K831798	I M, Inc.	DISPOSABLE SCALPELS	1983-07-19
K201622	Guangdong Kingfa Sci. & Tech.Co., Ltd.	Medical surgical mask	2020-11-24
K881618	3M Company	ASEPTEX 1809 FLUID-RESISTANT MOLDED SURGICAL MASK	1988-05-09
K883982	Iberhospitex, S.A.	DRENOVAC	1989-02-23
K852723	The Huxley Instrument Corp.	FOERSTER SPONGE FORCEPS, SERRATED, 7+SS 410 OR 420	1985-07-15

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2014	King Systems Corp.	1	King LTS-D Oropharyngeal Airways Product Usage: The King LTS-D is intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration and when the patient is considered to have a low risk of aspiration of stomach contents.
Z-0020-04	Vital Concepts, Inc.	1	Huntington Instruments brand Irrigation Aspiration System with Single Spike Tubing and 33 cm Probe, Disposable (single use only), sterile, latex free. Catalog # 55040. Labeled as Manufactured for Huntington Instruments, Ogden Utah.
Z-0021-04	Vital Concepts, Inc.	1	Irrigation Aspiration System with Double Spike Tubing and 33 cm Probe, Disposable (single use only), sterile, latex free. Catalog # 55060. HYDRO-PRO brand labeled as sold by Vital Concepts, Inc., Grand Rapids, Michigan. Huntington Instruments brand labeled as Manufactured for Huntington Instruments, Ogden Utah. Quanta Technologies L.L.C. brand Manufactured for Quanta Technologies, L.L.C., Tucson, AZ. Catalogue # 55060-10 sold in Canada and labeled as Manufactured for Jac-Cell Medic, Dorval, Quebec.
Z-0022-04	Vital Concepts, Inc.	1	HYDRO-PRO brand Irrigation Aspiration System with double Spike Tubing, no Probe, Disposable (single use only), sterile, latex free. Catalog # 55160. Vital Concepts, Inc., Grand Rapids, Michigan.
Z-0023-04	Vital Concepts, Inc.	1	HYDRO-PRO brand Suction-Irrigation System without Probe, Disposable (single use only), sterile, latex free. R-Med Re-Order # 55170R; Distributed by R-Med, Inc., Orgeon, OH

Similar Registrations

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3016871880	PRIMEX DESIGN & FABRICATION	Richmond, IN, US
3005360866	QEL DOMINICANA S.A.	ESPERANZA Valverde, DO
3010601984	Jiangsu Haize Medical Scientific Development Co.,Ltd.	Wuxi Jiangsu, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012314549. Last updated year: 2026. Please use registration number 3012314549 when referencing this establishment in official correspondence.