DEVICE: CVS Health (00050428065006)
Device Identifier (DI) Information
CVS Health
276878
In Commercial Distribution
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
276878
In Commercial Distribution
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Instant Cold Pain Relief Pack
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
No | |
Yes | |
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? |
---|---|---|---|---|
40555 | Hot/cold therapy pack, single-use |
A non-sterile device intended to be applied with or without pressure to the body surface (i.e., non-invasively) to provide heat and/or cold therapy for the skin and/or underlying tissues in the treatment of musculoskeletal pain and discomfort (e.g., from sports injuries or rheumatism). It consists of a compact envelope filled with a thermally-retentive material (e.g., silicate-based gel, peat) that can be heated and/or cooled. It may be shaped/sized to fit a specific anatomy or include a strap; it is not intended to support the neck. 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
3d91cca0-cf7e-488e-a0f2-185ff7afd83d
August 24, 2020
1
August 14, 2020
August 24, 2020
1
August 14, 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 |
---|---|---|---|---|---|
10050428065003 | 24 | 00050428065006 | In Commercial Distribution | box |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
60050428065008
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined