FDA UDI
In Commercial Distribution
🇺🇸 United States
Paxman cap kit
DI: B561PSCSKITLA251
·
Model: Large Asian, 25 credits
·
PAXMAN COOLERS LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Paxman cap kit
- Primary DI
- B561PSCSKITLA251
- Version / Model
- Large Asian, 25 credits
- Catalog Number
- PSCS-KIT-LA25
- Company Name
- PAXMAN COOLERS LIMITED
- Labeler DUNS
- 519917264
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-03-18
- Public Version
- 4
- Public Version Date
- 2025-05-16
- Public Version Status
- Update
- Public Device Record Key
- 8b3619fe-6edb-4bc6-9b05-1e21df58cf6c
Device Description
Paxman Cooling Cap Kit which consists of a Paxman Cooling Cap, haircare accessories and patient information on scalp cooling. The Paxman Cooling Cap consists of a silicone inner layer and neoprene outer cover that connects to the Paxman Scalp Cooling System (PSCS) to provide scalp cooling treatment.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PMC | Scalp Cooling System | General, Plastic Surgery | 878.4360 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62231 | Scalp cooling system, hair loss | An assembly of electrically-powered devices intended to reduce scalp hair loss associated with intravenous chemotherapy treatment by cooling the scalp to cause vasoconstriction and reduction of chemotherapy drug uptake by the follicular cells. It consists of a control unit which pumps a cooling agent to a head-worn cap containing coolant channels and temperature monitoring sensors. An insulating cap (e.g., neoprene) may be worn over the cooling cap to secure it and prevent condensation. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B561PSCSKITLA251 | HIBCC |
Customer Contacts
- Phone
- 844-572-9626
- [email protected]