FDA.reportPublic FDA data

Compact Burn Kit HA 6/cs BK11-HA

Primary DI
M689BK11HA00000030
Brand
Compact Burn Kit HA 6/cs BK11-HA
Company
Safeguard US Operating, LLC
Model
03
Catalog number
BK11-HA.00.000
Device description
Apart of the Water-Jel Emergency Burn Kits and Burn Stations family. This kit offers a versatile combination of Burn Dressings, Burn Wrap/Fire Blankets and Burn Jel to meet emergency burn care needs in all resource limited settings (RLS) to better meet the different work environments of emergency medical and rescue first responders. It is designed and intended for use by emergency medical, rescue and non-medical personnel.
Published
2026-11-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OJJBurn Kit Without Drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJJBurn Kit Without DrugGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M689BK11HA00000030PrimaryHIBCC0

Contacts#

Phone, Email table
PhoneEmail
855-428-6074sales@safeguardmedical.com

Regulatory Flags#

DUNS number
118492643
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M68938300010Burn Control Kit0138-3002026-11-05
M689BK10HA00000030Compact Burn Kit HA 6/cs BK10-HA03BK10-HA.00.0002026-11-05
M689EBK1HA00020Emergency Burn Kit Small, 6/cs First Responder HA02EBK1-HA.002026-11-05
M689EBK2HA00020Emergency Burn Kit Large, 3/cs First Responder HA02EBK2-HA.002026-11-05
M689EBK2HA24000020Emergency Burn Kit Large, 3/cs First Responder Canada02EBK2-HA.24.0002026-11-05
M689WJBBC300000050Bleeding Control Kit 3-Pcs in med kit box w/ bracket 6/cs05WJBBC3.00.0002026-11-05
M6898723101040Bleeding Control Kit0487-231-012026-10-22
M68981601030Rant Strategies K9 Trauma Kit0381-6012026-10-20
M689HHCWS01040Compact Wound Seal Kit04HHCWS012026-10-13
M689HHMTG01020MiniTAC Gauze02HHMTG012026-10-13
M689HVPIK060H-Vent Vented Chest Seal06HVPIK2026-10-13
M689TOCSEA030Curaplex TOCS03TOCS-EA2026-10-13
M689ATRPO1010Adult Trauma Response Pack1ATRP02022-06-07
M68931200070CrOC0731-2002026-10-08
M6898723101011Bleeding Control Kit0187-231-012022-09-15
M689SHSTARTPAXSM010SCHOOL TRAUMA ADVANCED RESPONSE KIT01SH-START-PAX-SM2022-09-26
M68981129060Mojo Patrol IFAK II0681-1292026-08-26
M689SDREDC1OTC050SDR-EDC1-OTC05SDR-EDC1-OTC2026-08-26
M689SDRTBBOTC060SDR Tactical Battle Belt IFAK-OTC06SDR-TBB-OTC2026-08-26
M68981139010LEO Patrol Kit0181-1392026-08-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956541979CARDINAL HEALTHCardinal Health 200, LLCOJJ2026-11-05
M68938300010Burn Control KitSafeguard US Operating, LLCOJJ2026-11-05
M689BK10HA00000030Compact Burn Kit HA 6/cs BK10-HASafeguard US Operating, LLCOJJ2026-11-05
M689EBK1HA00020Emergency Burn Kit Small, 6/cs First Responder HASafeguard US Operating, LLCOJJ2026-11-05
M689EBK2HA00020Emergency Burn Kit Large, 3/cs First Responder HASafeguard US Operating, LLCOJJ2026-11-05
M689EBK2HA24000020Emergency Burn Kit Large, 3/cs First Responder CanadaSafeguard US Operating, LLCOJJ2026-11-05
10198956559257CARDINAL HEALTHCardinal Health 200, LLCOJJ2026-09-04
10198956500099CARDINAL HEALTHCardinal Health 200, LLCOJJ2026-07-31
10198956534018CARDINAL HEALTHCardinal Health 200, LLCOJJ2026-07-27
10198956483804CARDINAL HEALTHCardinal Health 200, LLCOJJ2026-06-01
10194717121831Regard™ROI CPS, LLCOJJ2025-01-28
10195327596453Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJJ2024-07-29
10195327627782Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJJ2024-07-29
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10195327578848Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJJ2023-12-24
10195327494445Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJJ2023-12-21
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