DEVICE: ANF Therapy® (08436587171925)
Notice: Any discrepancies with this record compared to the label?
If so, send a picture of the label to
GUDIDSupport@fda.hhs.gov.
Device Identifier (DI) Information
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| No | |
| Yes | |
| No | |
| No | |
| No | |
| No | |
| No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
| GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
|---|---|---|---|---|
| 47363 | Physical therapy insulation patch |
A non-sterile device (a patch) intended to be applied externally to a body area to provide heat insulation to an inflamed joint, providing an analgesic effect alleviating localized pain in the joint. It is typically layered (e.g., an inner layer to retain heat and an outer layer to repel cold) and has an adhesive surface for adherence to the body surface. It is used for the treatment of local rheumatic conditions (e.g., joint and muscular pains, sports traumas, stiff neck, lumbago). It is typically available [non-prescription] over-the-counter (OTC). This is a single-use device.
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| IMD | Pack, Hot Or Cold, Disposable |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| Premarket Submission Number Not Available/Not Released | |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
8a61bc53-f0f9-4be4-9e84-843c9b8b958f
May 25, 2026
1
May 15, 2026
May 25, 2026
1
May 15, 2026
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| No Package DIs found | |||||
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)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined