FDA UDI
In Commercial Distribution
🇺🇸 United States
Medi-First Cold Spray
DI: 00347682230173
·
Model: 23017
·
Medique Products
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Medi-First Cold Spray
- Primary DI
- 00347682230173
- Version / Model
- 23017
- Catalog Number
- 23017
- Company Name
- Medique Products
- Labeler DUNS
- 086911794
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-07-12
- Public Version
- 1
- Public Version Date
- 2019-07-22
- Public Version Status
- New
- Public Device Record Key
- d947fc2e-8659-4ecc-bba2-f552a2efb1fc
Device Description
A non-sterile liquid in a spray container intended for localized application to the body surface to provide a cooling effect.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MLY | Refrigerant, Topical (Vapocoolant) | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46557 | Cold/cool therapy spray | A non-sterile liquid (e.g., alcohol based) in a spray container intended for localized application to the body surface to provide a cooling effect for underlying muscles/joints to reduce pain and swelling typically from sports injuries (cold therapy), and/or for cooling at the skin surface to treat heat rash or hot flushes (cool therapy); it may be intended to be applied to the skin directly or used in combination with a moist-cold pack/bandage (i.e., used to soak the moist-cold pack/bandage). After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50347682230178 | GS1 | master case | 12 | In Commercial Distribution | |
| Primary | 00347682230173 | GS1 |
Customer Contacts
- Phone
- 1-800-634-7680
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K033720 | 000 |