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Urine Monovette®, 10ML with luerlock

FDA UDI

Class I (US FDA UDI)

by Sarstedt, Inc.

Identity

Trade Name
Urine Monovette®, 10ML with luerlock FDA UDI
Generic Name
Non-evacuated urine specimen container IVD, no additive FDA UDI
Device Name
Urine Monovette®, 10ML with luerlock adapter assembled FDA UDI
Model / Reference
10.252.028 FDA UDI
Description
Urine Monovette®, 10ML with luerlock adapter assembled FDA UDI

Identifiers

Primary DI / UDI-DI
04038917075671 FDA UDI
FDA Product Code
KDT FDA UDI
GMDN Term
Non-evacuated urine specimen container IVD, no additive FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
864.3250 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Non-evacuated urine specimen container IVD, no additive

Urine Monovette®, 10ML with luerlock by Sarstedt, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Non-evacuated urine specimen container IVD, no additive.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sarstedt, Inc.

Sources (1)

  • FDA UDI d8a3942a-e0ca-4863-9bbe-de39c345a6dd 34 fields · synced Jun 1, 2026