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S-Monovette®

FDA UDI

Class II (US FDA UDI)

by Sarstedt Aktiengesellschaft & Co.KG

Identity

Trade Name
S-Monovette® FDA UDI
Generic Name
Non-evacuated erythrocyte sedimentation rate (ESR) tube IVD FDA UDI
Device Name
S-Monovette® 2ml 4NC FDA UDI
Model / Reference
05.1079.100 FDA UDI
Description
S-Monovette® 2ml 4NC FDA UDI

Identifiers

Catalog Number
05.1079.100 FDA UDI
Primary DI / UDI-DI
04038917125505 FDA UDI
FDA Product Code
JKA FDA UDI
GMDN Term
Non-evacuated erythrocyte sedimentation rate (ESR) tube IVD FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1675 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 erythrocyte sedimentation rate (ESR) tube IVD

S-Monovette® by Sarstedt Aktiengesellschaft & Co.KG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Non-evacuated erythrocyte sedimentation rate (ESR) tube IVD.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sarstedt Aktiengesellschaft & Co.KG

Sources (1)

  • FDA UDI 51c0a717-2202-43fe-b8f1-a568287397f1 35 fields · synced May 30, 2026