Cycler Drainage Bag

FDA UDI

Class II (US FDA UDI)

by Baxter International Inc.

Identity

Trade Name: Cycler Drainage Bag FDA UDI
Generic Name: Peritoneal dialysis system tubing set FDA UDI
Device Name: This product is to be used with Baxter APD Sets with Cassette. Baxter Manifold Sets and Extension Sets may also be used. Consult instructions for use. FDA UDI
Model / Reference: 5C4145P FDA UDI
Description: This product is to be used with Baxter APD Sets with Cassette. Baxter Manifold Sets and Extension Sets may also be used. Consult instructions for use. FDA UDI

Identifiers

Catalog Number: 5C4145P FDA UDI
Primary DI / UDI-DI: 00085412007410 FDA UDI
510(k) Number: K791899 FDA UDI
FDA Product Code: KDJ FDA UDI
GMDN Term: Peritoneal dialysis system tubing set 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

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

Yes

FDA UDI

Dimensions & Sizes

Size: Total Volume — 15 Liter FDA UDI

Category: Peritoneal dialysis system tubing set

Cycler Drainage Bag by Baxter International Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Peritoneal dialysis system tubing set.

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MiniCap — Baxter Healthcare Corp · Class II
VersiPD — Fresenius Medical Care Holdings, Inc. · Class II
Liberty® PDx — Fresenius Medical Care Holdings, Inc. · Class II

Cleared under the same submission

K791899 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: Baxter International Inc.

Sources (1)

FDA UDI 6f94c06a-3081-4e4c-8daf-56c3f542f63e 38 fields · synced May 30, 2026