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Apheresis Needle with MASTERGUARD™ Protector
FDA UDIClass II (US FDA UDI)
by Fenwal, Inc.
Identity
- Trade Name
- Apheresis Needle with MASTERGUARD™ Protector FDA UDI
- Generic Name
- Apheresis system tubing set FDA UDI
- Device Name
- Apheresis Needle with MASTERGUARD™ Protector 16 Ga. x 1-1/4'' BE (Back Eye). Sterile Fluid Path. FDA UDI
- Model / Reference
- 4R2440 FDA UDI
- Description
- Apheresis Needle with MASTERGUARD™ Protector 16 Ga. x 1-1/4'' BE (Back Eye). Sterile Fluid Path. FDA UDI
Identifiers
- Catalog Number
- 4R2440 FDA UDI
- Primary DI / UDI-DI
- 00811137012435 FDA UDI
- FDA Product Code
- FIE FDA UDI
- GMDN Term
- Apheresis system tubing set FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5540 FDA UDI
- Commercial Distribution
- Not 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
No
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
Apheresis Needle with MASTERGUARD™ Protector by Fenwal, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Fenwal, Inc.
Sources (1)
- FDA UDI cc6ba833-e0f1-431e-8ccd-c8dd5cdcbb2b 35 fields · synced May 31, 2026