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Salimetrics

FDA UDI

Class I (US FDA UDI)

by Salimetrics Llc.

Identity

Trade Name
Salimetrics FDA UDI
Generic Name
Oral/respiratory tract specimen container IVD, no additive/medium FDA UDI
Device Name
Salimetrics Cryovial, White 25/pk FDA UDI
Model / Reference
N/A FDA UDI
Description
Salimetrics Cryovial, White 25/pk FDA UDI

Identifiers

Catalog Number
5004.01 FDA UDI
Primary DI / UDI-DI
00859410006283 FDA UDI
FDA Product Code
NNK FDA UDI
GMDN Term
Oral/respiratory tract specimen container IVD, no additive/medium 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: Oral/respiratory tract specimen container IVD, no additive/medium

Salimetrics by Salimetrics Llc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Oral/respiratory tract specimen container IVD, no additive/medium.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Salimetrics Llc.

Sources (1)

  • FDA UDI ae5c0ec9-2050-47bc-86ad-ac3c0aa400ae 34 fields · synced Jun 8, 2026