← Back to catalogue

Crit-Line Cuvette

FDA UDI

Class II (US FDA UDI)

by LivaNova USA, Inc.

Identity

Trade Name
Crit-Line Cuvette FDA UDI
Generic Name
Arteriovenous/external shunt connector FDA UDI
Model / Reference
Crit-Line Cuvette FDA UDI

Identifiers

Primary DI / UDI-DI
00803622123139 FDA UDI
510(k) Number
K991986 FDA UDI
FDA Product Code
CAC FDA UDI
GMDN Term
Arteriovenous/external shunt connector FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.5830 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

Yes

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

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: Arteriovenous/external shunt connector

Crit-Line Cuvette by LivaNova USA, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Arteriovenous/external shunt connector.

Cleared under the same submission

K991986 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
LivaNova USA, Inc.

Sources (1)

  • FDA UDI 6c44faab-25da-4e72-a382-4bca372e5d56 33 fields · synced Jun 8, 2026