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Blood Gas Control - Level 2 (bg Control 2)

FDA UDI

Class I (US FDA UDI)

by Randox Laboratories, Ltd.

Identity

Trade Name
BLOOD GAS CONTROL - LEVEL 2 (BG CONTROL 2) FDA UDI
Generic Name
Multiple blood gas analyte IVD, control FDA UDI
Model / Reference
BG5002 FDA UDI

Identifiers

Catalog Number
BG5002 FDA UDI
Primary DI / UDI-DI
05055273227116 FDA UDI
510(k) Number
K093384 FDA UDI
FDA Product Code
JJY FDA UDI
GMDN Term
Multiple blood gas analyte IVD, control FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1660 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: Multiple blood gas analyte IVD, control

Blood Gas Control - Level 2 (bg Control 2) by Randox Laboratories, Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple blood gas analyte IVD, control.

Cleared under the same submission

K093384 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Randox Laboratories, Ltd.

Sources (1)

  • FDA UDI 75c9b98a-ab5c-47d9-aaab-406b63c0c586 34 fields · synced May 31, 2026