AccessGUDID - DEVICE: CareOne (00041520104861)

GUDID

Device Identifier (DI) Information

Brand Name: CareOne
Version or Model: 041520104861
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Ahold U.S.A., Inc.

Primary DI Number: 00041520104861
Issuing Agency: GS1
Commercial Distribution End Date: January 07, 2021
Device Count: 5
Labeler D-U-N-S® Number*: 170199058 *Terms of Use

Device Description: Hydrocolloid Blister Cushion, all one size, 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?
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: 995ce6fe-6983-4bed-83b7-2f42c51ddc01
Public Version Date: August 17, 2021
Public Version Number: 4
DI Record Publish Date: July 31, 2019

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
10041520104868	24	00041520104861	2021-01-07	Not in Commercial Distribution	case

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: 60041520104863 CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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