← Back to catalogue

SaliCaps

FDA UDI

Class I (US FDA UDI)

by IBL International GmbH

Identity

Trade Name
SaliCaps FDA UDI
Generic Name
General specimen container IVD, no additive/medium FDA UDI
Device Name
SaliCaps - 500 Tubes FDA UDI
Model / Reference
RE69995. FDA UDI
Description
SaliCaps - 500 Tubes FDA UDI

Identifiers

Catalog Number
RE69995. FDA UDI
Primary DI / UDI-DI
04049325003613 FDA UDI
510(k) Number
K040923 FDA UDI
FDA Product Code
JLS FDA UDI
GMDN Term
General specimen container IVD, no additive/medium FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1620 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: General specimen container IVD, no additive/medium

SaliCaps by IBL International GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General specimen container IVD, no additive/medium.

Cleared under the same submission

K040923 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
IBL International GmbH

Sources (1)

  • FDA UDI e73214a2-928a-4ac6-aed0-1a500c8177b6 37 fields · synced May 30, 2026