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BV Medical

FDA UDI

Class II (US FDA UDI)

by Medical, Inc.

Identity

Trade Name
BV Medical FDA UDI
Generic Name
Oxygen saturation/pulse rate electronic-signal simulator FDA UDI
Device Name
Finger Pulse Oximeter, Basic Adult Model, with Carrying Case FDA UDI
Model / Reference
50-100-004-L FDA UDI
Description
Finger Pulse Oximeter, Basic Adult Model, with Carrying Case FDA UDI

Identifiers

Primary DI / UDI-DI
00845821026507 FDA UDI
510(k) Number
K063641 FDA UDI
FDA Product Code
DQA FDA UDI
GMDN Term
Oxygen saturation/pulse rate electronic-signal simulator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.2700 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

No

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

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Oxygen saturation/pulse rate electronic-signal simulator

BV Medical by Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Oxygen saturation/pulse rate electronic-signal simulator.

Cleared under the same submission

K063641 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medical, Inc.

Sources (1)

  • FDA UDI 796ab2c4-f204-489d-b228-a055d431f00d 34 fields · synced May 30, 2026