KEMP LLC

FDA Device Registration & Listing · Charlotte, NC, US · Registration 3005621729

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3005621729
FEI Number
3005621729
Entity Name
KEMP LLC
City/State/Country
Charlotte, NC, US
Establishment Address
1900 Bancroft St, Charlotte, NC 28206, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
KEMP LLC (Owner Number: 9084061)
Owner / Operator Contact Address
1900 Bancroft St, Charlotte, NC 28206, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Finger Splint, Hand Splint Kemp USA Head Immobilizer Ambu BVM Kemp USA Fingertip Pulse Oximeter Tourniquets Cold & Hot Pack For First Aid, Disposable Adhesive Tapes and Bandages For First Aid Kemp USA RapidSeal® CPR Mask First Aid Kits (No Drugs) Emerald Nitrile Gloves Kemp USA Dressing, wound, hydrogel without drug and/or biologic C Oxygen Tank, D Oxygen Tank, Oxygen Tank Valve Regulator

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
ILH Splint, Hand, And Components Physical Medicine Class 1 890.3475 2025-03-13
CBP Valve, Non-Rebreathing Anesthesiology Class 2 868.5870 2016-09-23
NZD Stretcher, Patient Restraint General Hospital Class 1 880.6900 2025-02-05
BTM Ventilator, Emergency, Manual (Resuscitator) Anesthesiology Class 2 868.5915 2025-02-05
OCH Oximeter, Infrared, Sporting, Aviation Cardiovascular Class 2 870.2700 2025-01-21
KCY Tourniquet, Pneumatic General, Plastic Surgery Class 1 878.5910 2025-03-11
IMD Pack, Hot Or Cold, Disposable Physical Medicine Class 1 890.5710 2025-03-13
KGX Tape And Bandage, Adhesive General Hospital Class 1 880.5240 2025-03-11
KGB Mask, Oxygen, Non-Rebreathing Anesthesiology Class 1 868.5570 2024-11-26
OHO First Aid Kit Without Drug General, Plastic Surgery Class 1 878.4014 2025-02-05
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2025-02-05
MSH Respirator, Surgical General, Plastic Surgery Class 2 878.4040 2020-03-25
NAE Dressing, Wound, Hydrogel Without Drug And/Or Biologic General, Plastic Surgery Class 1 878.4022 2025-03-11
ECX Cylinder, Compressed Gas, And Valve Anesthesiology Class 1 868.2700 2025-03-13

Official Correspondent

EDDIE GULBENKIAN, III

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

KEMP LLC
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
K945177 Eagle Health Supplies 4-O2 JR. (CPR MOUTH BARRIER) 1994-11-01
K880871 John Wagner Associates, Inc. GRABBER WARM PACK/MINI MINI HEATER/FOOT HEATER 1988-05-20
K843874 Beiersdorf, Inc. LEUKOPOR SURGICAL TAPE 1985-02-21
K915446 Sun Glitz Corp. STRETCH WRAP 1992-05-06
K833120 Acme United Corp. ONE TIME COMPOUND BENZOIN TINCTURE- 1983-12-29

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0039-2010 Unomedical 2
Infant Manual Pulmonary Resuscitator with reservoir bag, face mask & Gas sampling elbow. Product ID # 5801, 12-8713, 732-E, and 2206. Packaged under the name of Dynarex, Evergreen, Mada and Hospitak. Recalled codes may be identified by examining the patient valve housing immediately below the right-angle exhalation port, where the retention ring should be visible. MPR units with a clear or transparent ring, as well as those where no ring can be seen, should be returned. MPR units with a blue retention ring are not affected and do not need to be returned.
Z-0040-2010 Unomedical 2
Pediatric Manual Pulmonary Resuscitator with reservoir bag, face mask & Gas sampling elbow. Product ID #s: 5804; 12-8709, 727-E; 727MM, 2203. Packaged under the name of Dynarex, Evergreen, Mada and Hospitak.
Z-0041-2010 Unomedical 2
Adult Manual Pulmonary Resuscitator with reservoir tube, face mask & Gas Sampling elbow. Product ID # 5807; 12-8703, 723-E (Foreign Distribution only), 723MM. Packaged under the name of Dynarex and Evergreen.
Z-0042-2010 Unomedical 2
Adult Manual Pulmonary Resuscitator with reservoir bag, face mask & Gas sampling elbow. Product ID #s 5808, 12-8704; 724-E; 724MM, 32612. Packaged under the name of Dynarex, Evergreen, Hospitak and Select Medical Products.
Z-0043-2010 Unomedical 2
Adult Manual Pulmonary Resuscitator with reservoir tube, face mask & standard elbow. Product ID #: 12-8702; 778500; 721-E, 778500; 2200; 2201, 86-721E, 40-116722 (foreign distributiuon only), 721MM. Packaged under the name of Evergreen, Hospitak, Kentron, McKesson and Mada.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005621729. Last updated year: 2026. Please use registration number 3005621729 when referencing this establishment in official correspondence.
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