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Cycler Drain Bag Set

FDA UDI

Class II (US FDA UDI)

by Fresenius Medical Care Holdings, Inc.

Identity

Trade Name
Cycler Drain Bag Set FDA UDI
Generic Name
Extracorporeal circuit waste bag FDA UDI
Model / Reference
026-20226A FDA UDI

Identifiers

Catalog Number
026-20226A FDA UDI
Primary DI / UDI-DI
00840861102037 FDA UDI
510(k) Number
K173363 FDA UDI
FDA Product Code
KDJ FDA UDI
GMDN Term
Extracorporeal circuit waste bag FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5630 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

No

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

Category: Extracorporeal circuit waste bag

Cycler Drain Bag Set by Fresenius Medical Care Holdings, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Extracorporeal circuit waste bag.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Fresenius Medical Care Holdings, Inc.

Sources (1)

  • FDA UDI 47336087-4f6f-48ee-b110-2edef872ab2a 36 fields · synced May 30, 2026