OTS - Class B Field Trauma - Hawkes Bag K616-002

GUDID 00766588160023

OTS - Class B Field Trauma - Hawkes Bag

Certified Safety Manufacturing, Inc.

Non-rebreathing valve, single-use
Primary Device ID00766588160023
NIH Device Record Key073eeafe-0f1a-45f7-993a-2b3fced926d6
Commercial Distribution StatusIn Commercial Distribution
Brand NameOTS - Class B Field Trauma - Hawkes Bag
Version Model NumberK616-002
Catalog NumberK616-002
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 Kitfalse
Device Combination Productfalse
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Phone+1(816)483-9090
EmailInfo@certifiedsafety.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100766588160023 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KGXTape and bandage, adhesive

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-03-21
Device Publish Date2018-11-16

Devices Manufactured by Certified Safety Manufacturing, Inc.

00766588244204 - Class A 21 Plus - 24 Poly White2025-04-04 Class A 21 Plus - 24 Poly White
00766588249070 - Class A 21 Assortment Pack2025-04-04 Class A 21 Assortment Pack
00766588249094 - Class A 21 Plus - 16 Poly White2025-04-04 Class A 21 Plus - 16 Poly White
00766588249186 - Class A 21 Plus - RTB 51862025-04-04 Class A 21 Plus - RTB 5186
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

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.