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5008X Fluid Sampling Accessory

FDA UDI

Class II (US FDA UDI)

by Fresenius Medical Care Renal Therapies Group, LLC

Identity

Trade Name
5008X Fluid Sampling Accessory FDA UDI
Generic Name
Haemodialysis dialysate sampling set FDA UDI
Model / Reference
04-9009-4 FDA UDI

Identifiers

Primary DI / UDI-DI
00840861102464 FDA UDI
510(k) Number
K231534 FDA UDI
K243505 FDA UDI
FDA Product Code
KOC FDA UDI
GMDN Term
Haemodialysis dialysate sampling set FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5820 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

Yes

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: Haemodialysis dialysate sampling set

5008X Fluid Sampling Accessory by Fresenius Medical Care Renal Therapies Group, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K231534 also covers:

K243505 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Fresenius Medical Care Renal Therapies Group, LLC

Sources (1)

  • FDA UDI 826229ca-c891-42ee-b3f6-b22c1412c5f8 35 fields · synced May 30, 2026