FDA UDI
In Commercial Distribution
🇺🇸 United States
PSCS Coolant
DI: B561COOLANTBATCH1
·
Model: Coolant Batch
·
PAXMAN COOLERS LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- PSCS Coolant
- Primary DI
- B561COOLANTBATCH1
- Version / Model
- Coolant Batch
- Catalog Number
- N/A
- Company Name
- PAXMAN COOLERS LIMITED
- Labeler DUNS
- 519917264
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-03-07
- Public Version
- 4
- Public Version Date
- 2025-05-16
- Public Version Status
- Update
- Public Device Record Key
- 129f77af-be77-42f1-a0ac-9e9e7e56aaae
Device Description
A consumable component of the Paxman Scalp Cooling System (PSCS) used as the cooling solution that is circulated within the system.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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 |
|---|---|---|---|---|
| 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 | B561COOLANTBATCH1 | HIBCC |
Customer Contacts
- Phone
- 844-572-9626
- [email protected]