AccessGUDID - DEVICE: CareOne (00041520104854)

GUDID

Device Identifier (DI) Information

Brand Name: CareOne
Version or Model: 041520104854
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Ahold U.S.A., Inc.

Primary DI Number: 00041520104854
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 6
Labeler D-U-N-S® Number*: 170199058 *Terms of Use

Device Description: Hydrocolloid Blister Cushions, assorted cushions, 0.66 in. x 2.32 in. (17mm x 59mm); 1.33 in. x 2.12in. (34mm x 54mm); 1.65 IN x 2.67 IN (42 mm x 68 mm)

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:	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?
62873	Exudate-absorbent dressing, hydrophilic-gel, non-sterile	A non-sterile adhesive covering intended to assist treatment and protection of fluid-filled superficial lesions (e.g., cold sores, mild acne spots/pimples, opened blisters) and/or minor abrasions by producing a water-absorbent gel upon contact with exudate and maintaining a moist environment; it does not contain an antimicrobial agent. It may be available in various forms (e.g., flat sheet/film, pad) and is typically made of hydrocolloid. It is normally available [non-prescription] over-the-counter (OTC). After application, this device cannot be reused.	Obsolete	false
61945	Corn/callus dressing, single-use	An adhesive dressing intended for protection of corns or calluses (hardened areas of skin on the feet or toes) or unopened blisters, and to maintain a moist environment to allow the lesion to heal. It consists of a pad of material (e.g., hydrocolloid) and may be impregnated with an acid (e.g., salicylic) which acts as a keratolytic agent to facilitate the removal of dead skin. It may be supplied with another dressing (e.g., ring) to provide additional protection/cushioning around the lesion. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NAD	Dressing, Wound, Occlusive

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: 31fcdf0d-27f5-47c1-bb55-5f32484b334c
Public Version Date: November 06, 2020
Public Version Number: 3
DI Record Publish Date: June 28, 2019