FDA.reportPublic FDA data

BleedStop™

Primary DI
00850817006241
Brand
BleedStop™
Company
Coag Medical, LLC
Model
BSP0060
Device description
BleedStop™ 60g pouch
Published
2025-07-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
QSYHemostatic Wound Dressing Without Thrombin Or Other Biologics

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QSYHemostatic Wound Dressing Without Thrombin Or Other BiologicsUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K140313000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140313000STOPSBLEEDING TOPICAL HEMOSTAT POWDER AND FOAMCoag Medical, LLC2014-07-28QSY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850817006241PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850817006241008508170062418508170062410850817006241

GMDN Terms#

Term, Definition table
TermDefinition
Plant polysaccharide haemostatic agent, bioabsorbableA bioabsorbable device derived from plant polysaccharides (e.g., starch, agar derivative, cellulose-derived) intended for topical application to a traumatic wound (e.g., abrasion, laceration, cut), ulcer, and/or surgical wound to facilitate local haemostasis; it is not dedicated to bone haemostasis. It is available in various forms (e.g., liquid, spray, foam, particles, foam pad/sponge, bandage strip, gauze pad) that can be applied directly to the wound where it remains to be absorbed by the body; it does not contain an antimicrobial agent. It may be used in combination with supplemental agents (e.g., vitamin K-dependent coagulation factors). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079736884
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850817006005BleedStop™BSP00152025-07-31
00850817006067BleedStop™BSP-NBS2025-07-31
00850817006111BleedStop™BSP05152025-07-31
00850817006135BleedStop™BSP03152025-07-31
00850817006142BleedStop™BSP02202025-07-31
00850817006159BleedStop™BSP03NBS2025-07-31
00850817006197StopsBleeding™SBP-NBS-A2025-07-31
00850817006210StopsBleeding™SBP00202025-07-31
00850817006227StopsBleeding™SBP00602025-07-31
00850817006234StopsBleeding™SBP01502025-07-31
00850817006258BleedStop™BSP00202025-07-31
00850817006265BleedStop™BSP04152025-07-31
00850817006326BleedStop™BSP01502025-07-31
00850817006456StopsBleeding™SBP00102025-07-31
00850817006463BleedStop™BSP04NBS2025-07-31
00850817006470StopsBleeding™SBP000D2025-07-31
00850817006494BleedStop™BSPNBSL2025-07-31

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Primary DI, Brand, Company table
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