Identity
- Trade Name
- Haemonetics® PCS®2, NexSys PCS™ & MCS®+ Systems FDA UDI
- Generic Name
- Apheresis system tubing set FDA UDI
- Device Name
- PLS Bag w/NaCl Spike FDA UDI
- Model / Reference
- 00692-00 FDA UDI
- Description
- PLS Bag w/NaCl Spike FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10812747011709 FDA UDI
- FDA Product Code
- GKT FDA UDI
- GMDN Term
- Apheresis system tubing set FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.9245 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
- Total Volume — 1000 Milliliter FDA UDI
Category: Apheresis system tubing set
Haemonetics® PCS®2, NexSys PCS™ & MCS®+ Systems by Haemonetics Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Apheresis system tubing set.
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- JMS SYSLOC APHERESIS NEEDLE SET — JMS SINGAPORE PTE LTD · Class II
- AMICUS Apheresis Kit - Functionally Closed Double Needle with PAS Spike — Fresenius Kabi · Class II
- JMS WINGEATER APHERESIS NEEDLE SET — JMS SINGAPORE PTE LTD · Class II
- Accessory Platelet Storage Sets — Terumo BCT, Inc.. · Class II
- Fenwal AMICUS Apheresis Kit-Double Needle w/Platelet Additive Solution Connector — Fresenius Kabi · 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
- Haemonetics Corporation
Sources (1)
- FDA UDI 5483546e-d036-4a18-b4be-b484d5a5eb54 36 fields · synced Jun 8, 2026