Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3041276591

FEI Number

3041276591

Entity Name

PUREBRAND SLUTIONS LTD

City/State/Country

London England, GB

Establishment Address

13 Hawley Crescent, Work Life, London England NW1 8NP, GB

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Purebrand Slutions LTD (Owner Number: 10094042)

Owner / Operator Contact Address

13 Hawley Crescent, Work Life, London, GB-ENG NW1 8NP, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K130040

PMA Number

N/A

All Registered Proprietary Names

BD TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION MOLNLYCKE TAPE, BANDAGE, ADHESIVE Welch Allyn LED Otoscope; Welch Allyn LumiView Clear Single-Use Ear Specula; MOLNLYCKE DRESSING, WOUND, DRUG,COMBINATION PRODUCT WELCH ALLYN-BP CUFF,DURASHOCK SPHYGMOMANOMETER,ACCESSORIES WELCH ALLYN- STETHOSCOPE, MANUAL BD CONTAINER, SPECIMEN TRANSPORT MOLNLYCKE DRESSING, WOUND AND BURN, OCCLUSIVE WELCH ALLYN-AUDIOMETER, POCKET FIBER OTOSCOPE, ACCESSORIES WELCH ALLYN-LS100 HALOGEN EXAMINATION LIGHT MOLNLYCKE DRESSING, WOUND, DRUG

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2026-04-22
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2026-04-22
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2026-04-22
ERA	Otoscope	Ear, Nose, Throat	Class 1	874.4770	2026-05-04
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2026-04-22
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2026-05-04
LDE	Stethoscope, Manual	Cardiovascular	Class 1	870.1875	2026-06-03
KDT	Container, Specimen Mailer And Storage, Sterile	Pathology	Class 1	864.3250	2026-04-22
MGP	Dressing, Wound And Burn, Occlusive	Unknown	Class U	N/A	2026-04-22
EWO	Audiometer	Ear, Nose, Throat	Class 2	874.1050	2026-05-04
KZF	Device, Medical Examination, Ac Powered	General Hospital	Class 1	880.6320	2026-05-04
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2026-04-22

Official Correspondent

Daniel Grinberg

US Agent Details

N/A Business: N/A Email: N/A

Related Public Records

Same Entity

Purebrand Slutions 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
K945777	Smiths Industries Medical Systems, Inc.	PRO-VENT(TM), PULSATOR(R), AND LINE DRAW(TM) ARTERIAL BLOOD SAMPLING SYRINGES	1994-12-22
K221518	Np Medical	NP Medical nCompass Extension Set with Stabilizing Base	2022-11-03
K953474	Medikmark, Inc.	IV START KIT	1995-10-02
K972493	Nipro Medical Corp.	NIPRO DISPOSABLE SOLUTION INFUSION SET	1997-09-18
K982672	Baxter Healthcare Corp	COLLEAGUE PUMP SYRINGE ADAPTER SET	1998-09-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0030-2014	Perkin Elmer Health Sciences, Inc.	2	Perkin Elmer 226 Sample Collection Device, Serial numbers: 06132903 - 06198900. The PerkinElmer 226 Sample Collection Devices are intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory, in newborn screening. The device includes a tear-apart form for the collection of demographic information.
Z-0010-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24
Z-0011-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24
Z-0012-2013	Baxter Healthcare Corp. Rt.	2	Baxter Interlink System Buretrol Solution Set with 150 mL Burette (Ball-Valve Drip Chamber); a sterile Rx IV fluid pathway device. Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.
Z-0012-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3041276591. Last updated year: 2026. Please use registration number 3041276591 when referencing this establishment in official correspondence.