Haemonetics® NexSys PCS® System

FDA UDI

Class II (US FDA UDI)

by Haemonetics Corporation

Identity

Trade Name: Haemonetics® NexSys PCS® System FDA UDI
Generic Name: Apheresis system tubing set FDA UDI
Device Name: 0625Q-00 Plasma Bowl FDA UDI
Model / Reference: 0625Q-00 FDA UDI
Description: 0625Q-00 Plasma Bowl FDA UDI

Identifiers

Primary DI / UDI-DI: 10812747019330 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

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Apheresis system tubing set

Haemonetics® NexSys PCS® System by Haemonetics Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Apheresis system tubing set.

ALYX 2RBC LR Kit with Saline Spike — FENWAL, INC. · Class II
Amicus Apheresis Kit - Functionally Closed Double Needle with PAS Spike and Dual — Fresenius Kabi · Class II
Amicus Double Needle Advanced Kit with Platelet Additive Solution Connector — Fresenius Kabi · Class II
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

Cleared under the same submission

BK220798 also covers:

HAEMONETICS PCS 300 PLASMA COLLECTION SYSTEM — HAEMONETICS CORPORATION

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Haemonetics Corporation

Sources (1)

FDA UDI d6911d20-4865-4fc2-943c-2dce0b636792 35 fields · synced Jun 8, 2026