16PW - Class A Burn 21 - Poly White K622-062

GUDID 00766588620626

16PW - Class A Burn 21 - Poly White

Certified Safety Manufacturing, Inc.

First aid kit, medicated
Primary Device ID00766588620626
NIH Device Record Keybfa9ab30-0d43-4e19-9f8c-ff662200f67a
Commercial Distribution StatusIn Commercial Distribution
Brand Name16PW - Class A Burn 21 - Poly White
Version Model NumberK622-062
Catalog NumberK622-062
Company DUNS788460483
Company NameCertified Safety Manufacturing, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Producttrue
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(816)483-9090
EmailInfo@certifiedsafety.com
Phone+1(816)483-9090
EmailInfo@certifiedsafety.com
Phone+1(816)483-9090
EmailInfo@certifiedsafety.com
Phone+1(816)483-9090
EmailInfo@certifiedsafety.com
Phone+1(816)483-9090
EmailInfo@certifiedsafety.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100766588620626 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LRRFirst Aid Kit with drug

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-11-08
Device Publish Date2022-10-31

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00766588257006 - Class A 21 Plus/CTB - 24 Poly White2025-04-04 Class A 21 Plus/CTB - 24 Poly White
00766588257013 - Class A 21 Plus/BBP - 24 Poly White2025-04-04 Class A 21 Plus/BBP - 24 Poly White
00766588257037 - Class A 21 Plus/BBP/CTB - 36 Metal2025-04-04 Class A 21 Plus/BBP/CTB - 36 Metal
00766588247045 - Heat Stress - 10 Poly White2025-04-01 Heat Stress - 10 Poly White

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