AccessGUDID - DEVICE: CareOne (00041520126634)

GUDID

Device Identifier (DI) Information

Brand Name: CareOne
Version or Model: 041520126634
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Ahold U.S.A., Inc.

Primary DI Number: 00041520126634
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 170199058 *Terms of Use

Device Description: Wound Care Kit, 40 pieces: 10 - Gauze Pads 4 IN x 4 IN (101 mm x 101 mm); 10 - Antiseptic Wipes 4.75 IN x 7.75 IN (120 mm x 196 mm); ; 12 – Non-stick Pads 3 IN x 4 IN (76 mm x 101 mm); 4 – Transparent Dressings 2.36 IN x 2.75 IN (59 mm x 69 mm); 3 – Rolled Gauze 4 IN x 2.5 YD (101 mm x 2.28 m); 1 – Paper Tape 1 IN x 10 YD (25 mm x 9.14 m);

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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	Yes
Combination Product:	Yes
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?
44039	First aid kit, medicated	A convenient collection of equipment, materials and pharmaceuticals intended to be used in an emergency for the rapid, initial treatment of an injury. It is typically used by emergency medical services (EMS), hospitals, institutions, schools, and other public settings. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LRR	First Aid Kit With Drug

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
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
No Device Sizes

Device Record Status

Public Device Record Key: e518a6c7-eabd-4c36-9723-a489ed765988
Public Version Date: October 05, 2020
Public Version Number: 1
DI Record Publish Date: September 27, 2020