Identity
- Trade Name
- PH Band FDA UDI
- Generic Name
- Radial artery compression device FDA UDI
- Device Name
- PH Band FDA UDI
- Model / Reference
- 41111-01 FDA UDI
- Description
- PH Band FDA UDI
Identifiers
- Catalog Number
- PHB-001U FDA UDI
- Primary DI / UDI-DI
- 00860006401702 FDA UDI
- 510(k) Number
- K201695 FDA UDI
- FDA Product Code
- DXC FDA UDI
- GMDN Term
- Radial artery compression device FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4450 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Radial artery compression device
PH Band by Medical Ingenuities — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Radial artery compression device.
- PreludeSYNC™ — Merit Medical Systems, Inc. · Class II
- PreludeSYNC DISTAL™ — Merit Medical Systems, Inc. · Class II
- Cordis Zephyr Vascular Compression Band — Semler Technologies, Inc. · Class II
- MEDADV — MEDAS, INC. · Class II
- HemCon® ChitoPulse™, 15 inch — Tricol Biomedical, INC. · Class II
- PreludeSYNC™ — Merit Medical Systems, Inc. · Class II
- TRAcelet™ — MEDTRONIC, INC. · Class II
- PreludeSYNC DISTAL™ — Merit Medical Systems, Inc. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Medical Ingenuities
Sources (1)
- FDA UDI 1623304b-b5d6-40e8-972e-e8cfce345ef0 36 fields · synced May 31, 2026