FDA.reportPublic FDA data

Control the Bleed Pack

Primary DI
00766588268590
Brand
Control the Bleed Pack
Company
Certified Safety Manufacturing, Inc.
Model
KR626-859
Catalog number
KR626-859
Device description
Control the Bleed Pack
Published
2026-11-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LRRFirst Aid Kit with drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRRFirst Aid Kit With DrugUnknownN

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K940249000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K940249000CERTIBURN BURN/TRAUMA FACE DRESSING /TOWEL DRESSINGCertified Safety Mfg., Inc.1994-10-03LRR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00766588268590PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00766588268590007665882685907665882685900766588268590

Contacts#

Phone, Email table
PhoneEmail
+1(816)483-9090Info@certifiedsafety.com

Regulatory Flags#

DUNS number
788460483
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
false
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
00766588268873Utilimaster - 10 Poly WhiteK626-887K626-8872026-10-08
00766588260143Watercraft First Aid Kit - 16 Poly WhiteK626-014K626-0142026-08-19
00766588260181Teichert Clas A 21 - 18 MetalK626-018K626-0182026-08-19
00766588260112Class A 21 - Grab-N-Go Large - Red Velcro BagK626-011K626-0112026-06-04
00766588283463Cohesive Wrap - 2"x 5 ydsR228-346R228-3462026-06-04
10766588283460Cohesive Wrap - 2"x 5 yds - UDI/10R228-346R228-3462026-06-04
00766588260037Naloxone - 16 Poly ClearK626-003K626-0032026-05-26
00766588420103Forceps - MagnifierR242-010R242-0102026-05-26
10766588420100Forceps - Magnifier UDI/10R242-010R242-0102026-05-26
00766588260099Cement Burn Cabinet - 75H 2 Shelf CabinetK626-009K626-0092026-05-04
00766588090177FAA SWA on Board PPE Bag - ZLBFK209-017FK209-0172026-04-29
00766588090160FAA SWA BioHazard Clean Up Bag - ZLBFK209-016FK209-0162026-04-16
00766588260044Class B 21 BloodBorne Pathogen - 75H CabinetK626-004K626-0042026-04-16
00766588260075So Cal Gas Wilderness Tactical Class B 21 - Jump Bag 5210K626-007K626-0072026-04-16
00766588260020Naloxone - 10 Poly WhiteK626-002K626-0022026-04-06
00766588260068Burn Dressing Large - Red Velcro BagK626-006K626-0062026-04-06
00766588247045Heat Stress - 16 Poly WhiteK624-904K624-9042025-03-24
00766588260051Burn Dressing Small - Red Velcro BagK626-005K626-0052026-03-23
00766588127675RR - UP Vehicle - 75 RefillKR612-067KR612-0672026-03-02
00766588249810Class B 21 ANSI Plus - RTB 5186K624-981K624-9812026-03-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00020424200848BE SMART GET PREPAREDTOTAL RESOURCES INTERNATIONAL INC.LRR2026-11-04
00842209140626NARNORTH AMERICAN RESCUE, LLCLRR2026-10-27
00850070635271Response Plus kitNar Medical Depot, LLCLRR2026-10-23
00860014697340RiskWise Health KitsRiskWise Supplies LLCLRR2026-10-23
00860014697357RiskWise Health KitsRiskWise Supplies LLCLRR2026-10-23
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06942509220944ColiahJeeasdenYiwu Ori-Power Medtech Co.,Ltd.LRR2026-10-23
06942509220982OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-10-23
06942509220999OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-10-23
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06942509221019OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-10-23
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06942509221101avalancheYiwu Ori-Power Medtech Co.,Ltd.LRR2026-10-23
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06942509221224OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-10-23