AccessGUDID - DEVICE: RENPHO heating pad (16971912180016)

GUDID

Device Identifier (DI) Information

Brand Name: RENPHO heating pad
Version or Model: NA-H1821B
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: NINGBO BELLA VIE CO., LTD

Primary DI Number: 16971912180016
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 561007300 *Terms of Use

Device Description: No description.

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?
64765	Hot/cold therapy system	An electrically-powered assembly of devices intended to apply controlled heat and cold therapy (including contrast therapy) to the surface of the body for a variety of physiotherapy applications such as treatment of musculoskeletal pain, inflammation reduction, and analgesia during intramuscular injection. It includes both a control unit and a handpiece with a heating/cooling endpiece; liquid coolant is used to provide the cooling effect.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IRT	Pad, Heating, Powered

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: 43e3e238-324f-4202-b867-d87dea20be85
Public Version Date: April 08, 2021
Public Version Number: 1
DI Record Publish Date: March 31, 2021

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
26971912180013	12	16971912180016		In Commercial Distribution	Box

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: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

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

Customer Contact

[?]

No Customer Contact currently defined

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