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BB-613 BPM 16-Unit Multipack

FDA UDI

Class II (US FDA UDI)

by Bio-Beat Technologies , Ltd.

Identity

Trade Name
BB-613 BPM 16-Unit Multipack FDA UDI
Generic Name
Multiple physiological parameter spot-check system, clinical FDA UDI
Model / Reference
2.1.0 FDA UDI

Identifiers

Catalog Number
BB900000200016 FDA UDI
Primary DI / UDI-DI
17290020154405 FDA UDI
510(k) Number
K241066 FDA UDI
FDA Product Code
DXN FDA UDI
GMDN Term
Multiple physiological parameter spot-check system, clinical FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1130 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 BPM 16-Unit Multipack by Bio-Beat Technologies , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Cleared under the same submission

K241066 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bio-Beat Technologies , Ltd.

Sources (1)

  • FDA UDI b0edd945-cff1-4e2d-b3a2-6ae43c20d7fa 34 fields · synced May 31, 2026