Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3030078769

FEI Number

3030078769

Entity Name

INTEGRATED MEDCRAFT LLC

City/State/Country

East Hampton, CT, US

Establishment Address

1 Sinco Pl, Unit A10, East Hampton, CT 06424, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Integrated Medcraft LLC (Owner Number: 10089406)

Owner / Operator Contact Address

1 Sinco Pl, Unit A10, East Hampton, CT 06424, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

FORWARD AAJT Deployment Kit APLS Gurney Guard APLS Litter Guard APLS Surgical Soaker Forward Thorasite with Pneumodart, 14G FORWARD Oral Airway Kit APLS Thermal Guard APLS Thermal Wrap APLS Litter Guard APLS Life Guard APLS Thermal Guard Mylar APLS Transport with Comfort Plus APLS Transport FORWARD® Finger Thoracostomy Kit - Single Side EMS Chest Tube Insertion Kit, 24F FORWARD® Finger Thoracostomy Kit-Bilateral FORWARD® EMS Chest Tube Insertion Kit, 28Fr FOWARD APLS Body Guard FORWARD Heat - Life Guard APLS Emergency Blanket FORWARD Heat - Emergency Blanket K9 Naloxone Kit, in Pouch FORWARD Naloxone HCL Kit, In Pouch FORWARD Opioid Overdose Kit Enforcement Group Medical Bag FORWARD Enforcement Group Medical Bag Forward Finger Thoracostomy Kit - Single Side Finger Thorcastomy Kit Forward Finger Thoracostomy Kit-Bilateral FORWARD IO Infusion Kit FORWARD® Intraosseous Infusion Bundle FORWARD Field Intubation Kit Forward Thorasite with Pneumodart, 14G

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2024-01-16
FMW	Cover, Mattress (Medical Purposes)	General Hospital	Class 1	880.6190	2025-03-31
GAA	Needle, Aspiration And Injection, Disposable	General, Plastic Surgery	Class 1	878.4800	2026-06-04
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	Class 1	868.5110	2024-12-30
FMR	Device, Transfer, Patient, Manual	General Hospital	Class 1	880.6785	2025-03-31
PYI	Thoracic Catheter Insertion Tray	General, Plastic Surgery	Class 1	878.4200	2025-07-21
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2025-02-20
LRR	First Aid Kit With Drug	Unknown	Class N	N/A	2025-02-18
LRO	General Surgery Tray	General, Plastic Surgery	Class 2	878.4370	2026-03-03
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2024-01-16
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2024-01-16
GBX	Catheter, Irrigation	General, Plastic Surgery	Class 1	878.4200	2026-06-04

Official Correspondent

Richard Barber

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Integrated Medcraft 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
K781371	Ferris Mfg. Corp.	BONE MARROW ASPIRATION KIT	1978-09-20
K961683	J.J. Skinner, Inc.	JJ SKINNER CAREKITS MINOR SURGICAL PROCEDURE TRAY	1996-05-10
K812404	Nu Tech Medical Systems	BUTTERFLY NEEDLE ASSEMBLY	1981-09-09
K233341	Covidien, LLC	Shiley Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440, 87445, 87450, 87455, 87460, 87465, 87470, 87475, 87480, 87485, 87490, 87495, 87410)	2024-05-20
K243785	Covidien, LLC	Shiley Oral/Nasal Tracheal Tube with TaperGuard Cuff Reinforced, Murphy Eye Shiley Tracheal Tube TaperGuard Cuff Reinforced with Stylet Shiley Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced Shiley Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced, Murphy Eye Shiley Oral/Nasal Tracheal Tube Cuffless Reinforced	2025-09-25

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0017-2023	Hobbs Medical, Inc.	1	Hobbs Transbronchial Aspiration Needle and Vacu-lok Aspirating Syringe Catalog Number: 4620
Z-0018-2023	Hobbs Medical, Inc.	1	Hobbs Transbronchial Aspiration Needle Catalog Number: 4621
Z-0023-2011	Becton Dickinson & Company	1	BD 30G1/2 PrecisionGlide Needle;Catalog/Lot Number: 305106. Needles are intended for use in aspiration and injection of medications.
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-0027-2025	Windstone Medical Packaging, Inc.	2	Aligned Medical Tonsil Tray REF AMS9300A that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.

Similar Registrations

Registration Number	Establishment Name	Location
1531062	E-BEAM SERVICES, INC.	LEBANON, OH, US
9680515	TONTARRA MEDIZINTECHNIK GMBH	WURMLINGEN Baden-Wurttemberg, DE
1055236	DEROYAL INDUSTRIES, INC.	NEW TAZEWELL, TN, US
2950160	WRIGHT ENGINEERED PLASTICS, INC.	Santa Rosa, CA, US
3005809810	Jarit GmbH	Rietheim-Weilheim Baden-Wurttemberg, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3030078769. Last updated year: 2026. Please use registration number 3030078769 when referencing this establishment in official correspondence.