Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009662219

FEI Number

3009662219

Entity Name

Custom Medical and Safety Products Inc.

City/State/Country

Buffalo, NY, US

Establishment Address

1100 Military Rd, Buffalo, NY 14217, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Custom Medical and Safety Products Inc. (Owner Number: 10040872)

Owner / Operator Contact Address

1100 Military Road, Buffalo, NY 14217, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

B8 Sales Tapes, Bandages, Adhesives Coolbaze, , SB-7260-P,Fire Blanket, 6ft x 5ft (183cm x 152cm) In Foil Pouch, 4 per case Coolbaze, , 1216-20,Face Mask/Burn Dressing, 12 x 16 (30cm x 40cm), 20 per case Coolbaze, , RBKS-12,Restaurant Burn Kit, Small, 12/per case Coolbaze, , BF00293,Good Sense Burn Gel, 4oz Bottle in Retail Box, 24 per case Coolbaze, , SD-6,Single Dose, 6/box 1/8 oz (3.5gm), 100 per case Coolbaze, , EDBK-12,Everyday Burn Kit 12/per case Coolbaze, , 0206-60,Burn Dressing, 2 x 6 (5cm x 15cm), 60 per case Coolbaze, , 0818-20,Burn Dressing, 8 x 18, 20 per case Coolbaze, , 0808-30,Burn Dressing, 8 x 8 (20cm x 20cm), 30 per case Coolbaze, , PL4B1P-24,Rest. Depot P/L 4oz Burn Gel 24/per case Coolbaze, , 4B-01,Burn Gel, 4 oz (118 ml) Bottle Coolbaze, , SD-1000,Single Dose, Bulk 1/8 oz (3.5gm), 1000 per case Coolbaze, , MPBK-2,Medical Professional Burn Kit, 2 per/case Coolbaze, , EMBK-10,Emergency Burn Kit, 10/per case Coolbaze, , 4BR-24,Burn Gel, 4oz Bottle in Retail Box, 24 per case Coolbaze, , 1GR-1000,1 Gram, Bulk 1/32 oz (.9gm), 1000 per case Coolbaze, , 0416-28,Burn Dressing, 4 x 16, 28 per case Coolbaze, , SB-3630-P,Fire Blanket, 36 x 30 (91cm x 76cm) In Foil Pouch, 4 per case Coolbaze, , PMBK-20,Promo Burn Kit, 20 per case Coolbaze, , SB-7260,Fire Blanket, 6ft x 5ft (183 cm x 152 cm) In Canvas Bag Coolbaze, , SB-3630,Fire Blanket, 36 x 30 (91cm x 76 cm) In Canvas Bag Coolbaze, , RBKL-10,Restaurant Burn Kit, Large, 10/per case Coolbaze, , 0202-120,Burn Dressing, 2 x 2 (5cm x 5cm), 120 per case Coolbaze, , SD-25,Single Dose, 25/box 1/8 oz (3.5gm), 24 per case Coolbaze, , 4B-24,Burn Gel, 4 oz (118 ml) Bottle, 24 per case Coolbaze, , 0404-60,Burn Dressing, 4 x 4 (10cm x 10cm), 60 per case Coolbaze, , 2B-48,Burn Gel, 2oz (59 ml) Bottle, 48 per case Coolblaze Burn Gel Coolblaze Fire Blanket CoolBlaze Burn Dressing

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2017-01-06
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2012-08-27

Official Correspondent

Paul Brindley

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Custom Medical and Safety Products Inc.

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
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
K870091	Avery Intl.	IV SECUREMENT DEVICE USING PCCE THERMO. FILM	1987-02-04

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009662219. Last updated year: 2026. Please use registration number 3009662219 when referencing this establishment in official correspondence.