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Decathlon DF Long-Term Hemodialysis Catheter

FDA UDI

Class II (US FDA UDI)

by Bard Access Systems, Inc.

Identity

Trade Name
Decathlon DF Long-Term Hemodialysis Catheter FDA UDI
Generic Name
Double-lumen haemodialysis catheter, implantable FDA UDI
Device Name
DECATHLON DF HEMODIALYSIS CATH, AIRGUARD, 16 FR. 50cm FDA UDI
Model / Reference
DF50SH55K FDA UDI
Description
DECATHLON DF HEMODIALYSIS CATH, AIRGUARD, 16 FR. 50cm FDA UDI

Identifiers

Catalog Number
DF50SH55K FDA UDI
Primary DI / UDI-DI
00801741014048 FDA UDI
FDA Product Code
MSD FDA UDI
GMDN Term
Double-lumen haemodialysis catheter, implantable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5540 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

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
Catheter Gauge — 16 French FDA UDI
Length — 50 Centimeter FDA UDI

Category: Double-lumen haemodialysis catheter, implantable

Decathlon DF Long-Term Hemodialysis Catheter by Bard Access Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Double-lumen haemodialysis catheter, implantable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bard Access Systems, Inc.

Sources (1)

  • FDA UDI c62eebe7-595b-407a-81aa-cd21a6362982 36 fields · synced Jun 9, 2026