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BS-480 Common Maintenance Kit(FDA)

FDA UDI

Class II (US FDA UDI)

by Shenzhen Mindray Bio-Medical Electronics Co.

Identity

Trade Name
BS-480 Common Maintenance Kit(FDA) FDA UDI
Generic Name
Multiple clinical chemistry analyser IVD, laboratory FDA UDI
Model / Reference
115-028324-00 FDA UDI

Identifiers

Primary DI / UDI-DI
06944904084527 FDA UDI
510(k) Number
K140690 FDA UDI
FDA Product Code
JGS FDA UDI
GMDN Term
Multiple clinical chemistry analyser IVD, laboratory FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1665 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Multiple clinical chemistry analyser IVD, laboratory

BS-480 Common Maintenance Kit(FDA) by Shenzhen Mindray Bio-Medical Electronics Co. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple clinical chemistry analyser IVD, laboratory.

Cleared under the same submission

K140690 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Shenzhen Mindray Bio-Medical Electronics Co.

Sources (1)

  • FDA UDI b68ef409-8441-4c76-8d9e-15d0a8441de9 34 fields · synced May 30, 2026