Identity
- Trade Name
- masterguard APHERESIS NEEDLE FDA UDI
- Generic Name
- Non-fixed blood collection needle FDA UDI
- Model / Reference
- P9-7006MGLB FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00842289102668 FDA UDI
- FDA Product Code
- FIE FDA UDI
- GMDN Term
- Non-fixed blood collection needle FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5540 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
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
Dimensions & Sizes
- Size
- Needle Gauge — 16 Gauge FDA UDILength — 1 Inch FDA UDI
Category: Non-fixed blood collection needle
masterguard APHERESIS NEEDLE by NxStage Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Non-fixed blood collection needle.
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- Marketlab Inc — MARKETLAB INC. · Class II
- IMPROSAFE® Multi Sample Needle — Guangzhou Improve Medical Instruments Co., Ltd. · Class II
- IMPROSAFE® Blood Collection Set with Pre-Attached Holder — Guangzhou Improve Medical Instruments Co., Ltd. · 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
- NxStage Medical, Inc.
Sources (1)
- FDA UDI adb11187-7d02-4ddd-aece-86d793a3b468 35 fields · synced Jun 9, 2026