AccessGUDID - DEVICE: BleedCEASE® (10860008863314)

GUDID

Device Identifier (DI) Information

Brand Name: BleedCEASE®
Version or Model: CAT BC-25
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CAT BC-25
Company Name: Carencease Healthcare LLC

Primary DI Number: 10860008863314
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 25
Labeler D-U-N-S® Number*: 080452143 *Terms of Use

Device Description: BleedCease, Sterile, 25 Pack

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
47011	First aid absorbent pad/bandage	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FRO	Dressing, Wound, Drug
EMX	Balloon, Epistaxis

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Width: .75 Inch
Length: 1.5 Inch

Device Record Status

Public Device Record Key: dcbbcd09-5725-44dc-b16c-cb66d6f10488
Public Version Date: December 18, 2024
Public Version Number: 1
DI Record Publish Date: December 10, 2024