AccessGUDID - DEVICE: ViveCare (00810113576695)

GUDID

Device Identifier (DI) Information

Brand Name: ViveCare
Version or Model: RHB3021OZ3
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: VIVE HEALTH LLC

Primary DI Number: 00810113576695
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 047025993 *Terms of Use

Device Description: Silver Anti-Microbial Wound Gel

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:	No
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?
63108	Skin semi-occlusive dressing, antimicrobial	A substance (e.g., gel, cream, ointment) intended to be topically applied to injured/diseased skin to expedite skin healing and re-epithelialization primarily through semi-occlusive properties which reduce moisture transmission from the wound to the environment by means of a physical barrier; it also includes an antimicrobial agent(s). It is intended for home/healthcare facility use to treat open skin wounds (e.g., abrasions, lacerations, burns, surgical wounds, ulcers) and/or conditions (e.g., eczema, psoriasis, scars). After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FRO	Dressing, Wound, Drug

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: 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: cbe6723a-4ab6-42f4-8fa9-652df46231b4
Public Version Date: March 10, 2025
Public Version Number: 2
DI Record Publish Date: August 20, 2024

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
10810113576692	60	00810113576695		In Commercial Distribution	Case

Secondary DI

[?]

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

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: Yes
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: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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