← Back to catalogue

BB-613 H@H kit

FDA UDIEUDAMED

Class II (US FDA UDI)

by Bio-Beat Technologies , Ltd.

Identity

Trade Name
BB-613 H@H kit FDA UDI
Generic Name
Multiple physiological parameter spot-check system, clinical FDA UDI
Model / Reference
2.1.0 FDA UDI

Identifiers

Catalog Number
BB90000200003 FDA UDI
Primary DI / UDI-DI
07290020154309 FDA UDI
510(k) Number
K222010 FDA UDI
FDA Product Code
DQA FDA UDI
DXN FDA UDI
DRG FDA UDI
BZQ FDA UDI
FLL FDA UDI
DXG FDA UDI
GMDN Term
Multiple physiological parameter spot-check system, clinical FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.2700 FDA UDI
870.1130 FDA UDI
870.2910 FDA UDI
868.2375 FDA UDI
880.2910 FDA UDI
870.1435 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

No

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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Multiple physiological parameter spot-check system, clinical

BB-613 H@H kit by Bio-Beat Technologies , Ltd. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Multiple physiological parameter spot-check system, clinical.

Cleared under the same submission

K222010 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Bio-Beat Technologies , Ltd.

Sources (2)

  • FDA UDI 1b48114c-4b92-4b6a-885d-f17effe3b9ac 34 fields · synced Jun 18, 2026
  • EUDAMED 1 fields · synced Jun 4, 2026