Haemonetics® PCS®2 & NexSys PCS™ Systems

FDA UDI

Class II (US FDA UDI)

by Haemonetics Corporation

Identity

Trade Name: Haemonetics® PCS®2 & NexSys PCS™ Systems FDA UDI
Generic Name: Apheresis system tubing set FDA UDI
Device Name: Plasma Bottles with Saline Adapter FDA UDI
Model / Reference: 0694S-00 FDA UDI
Description: Plasma Bottles with Saline Adapter FDA UDI

Identifiers

Primary DI / UDI-DI: 30812747011673 FDA UDI
FDA Product Code: KSR FDA UDI
GMDN Term: Apheresis system tubing set FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 864.9100 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

Dimensions & Sizes

Size: Total Volume — 1000 Milliliter FDA UDI

Category: Apheresis system tubing set

Haemonetics® PCS®2 & NexSys PCS™ Systems 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

BK020001 also covers:

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 d0a04248-e15b-4663-97dd-ce12920c6171 36 fields · synced Jun 8, 2026