← Back to catalogue

Hach

FDA UDI

Class II (US FDA UDI)

by Hach Company

Identity

Trade Name
HACH FDA UDI
Generic Name
Haemodialysis system chlorine monitor FDA UDI
Device Name
PERFORMANCE CHECK KIT, CM130 FDA UDI
Model / Reference
9746600 FDA UDI
Description
PERFORMANCE CHECK KIT, CM130 FDA UDI

Identifiers

Catalog Number
9746600 FDA UDI
Primary DI / UDI-DI
00851575007273 FDA UDI
510(k) Number
K162471 FDA UDI
FDA Product Code
FIP FDA UDI
PSX FDA UDI
GMDN Term
Haemodialysis system chlorine monitor FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5665 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

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

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

Category: Haemodialysis system chlorine monitor

Hach by Hach Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Haemodialysis system chlorine monitor.

Cleared under the same submission

K162471 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Hach Company

Sources (1)

  • FDA UDI d81514a6-746f-49fe-9cb0-01e788f83fae 37 fields · synced Jun 8, 2026