AccessGUDID - DEVICE: VIVE (00810041981530)

GUDID

Device Identifier (DI) Information

Brand Name: VIVE
Version or Model: RHB1049
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: VIVE HEALTH LLC

Primary DI Number: 00810041981530
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 047025993 *Terms of Use

Device Description: Ice Machine Therapy

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?
36034	Cold therapy pack chilling unit	A mains electricity (AC-powered) device used to chill the contents of a reusable cold therapy pack or hot/cold therapy pack to temperatures appropriate to apply cold therapy to the human body. This device, also known as a hydrocollator, typically consists of a stainless steel container, shelves, trays, or drawers that facilitate the chilling and handling of the many cold therapy packs, and chilling elements (e.g., integral coils) that create temperatures of around minus 17? Celsius. It is typically used in accident and emergency (A&E) rooms, rehabilitation facilities and for physiotherapy treatments.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ILO	Pack, Hot Or Cold, Water Circulating

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: 0feb7bfc-cf8f-4084-b930-ceab3cc72911
Public Version Date: March 06, 2020
Public Version Number: 1
DI Record Publish Date: February 27, 2020

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
10810041981537	1	00810041981530		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: No
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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