FDA.reportPublic FDA data

BleedCEASE®

Primary DI
10860008863321
Brand
BleedCEASE®
Company
Carencease Healthcare LLC
Model
CAT BC-100
Catalog number
CAT BC-100
Device description
BleedCease, Sterile, 100 Pack
Published
2024-12-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYASplint, Intranasal SeptalEar, Nose, Throat1
QSYHemostatic Wound Dressing Without Thrombin Or Other BiologicsUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30860008863325PackageGS112In Commercial Distribution
10860008863321PrimaryGS10
00860008863324Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3086000886332530860008863325
1086000886332110860008863321
00860008863324008600088633248600088633240860008863324

GMDN Terms#

Term, Definition table
TermDefinition
First aid absorbent pad/bandageA wound cover intended to be used as an initial, short-term treatment after injury that consists of an absorbent pad (e.g., gauze, cotton wool, lint, cellulose) that is attached to a roll bandage (e.g., cotton or cotton/viscose). The pad is applied directly to the wound, and the bandage is subsequently wrapped around the pad and secured. The device is intended for use in the home or a clinical setting to protect wounds, arrest bleeding, and introduce medications placed on the pad. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length1.5Inch
Width0.75Inch

Contacts#

Phone, Email table
PhoneEmail
585-624-7540info@catalina-healthcare.com

Regulatory Flags#

DUNS number
080452143
Device count
100
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10860008863307BleedCEASE®CAT BC-5CAT BC-52024-12-10
10860008863314BleedCEASE®CAT BC-25CAT BC-252024-12-10
10860008863338NasalCEASE®CAT NAS-5CAT NAS-52024-12-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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00810194401756AiraAIRA, LLCQSY2026-03-13
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