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Bio-Probe®

FDA UDI

Class II (US FDA UDI)

by Medtronic, Inc.

Identity

Trade Name
BIO-PROBE® FDA UDI
Generic Name
Blood flowmeter transducer, non-indwelling FDA UDI
Device Name
PROBE 95244 BIO-PROBE 12PK DP38 ST PLYC FDA UDI
Model / Reference
95244 FDA UDI
Description
PROBE 95244 BIO-PROBE 12PK DP38 ST PLYC FDA UDI

Identifiers

Primary DI / UDI-DI
00885074495743 FDA UDI
510(k) Number
K830858 FDA UDI
FDA Product Code
DPT FDA UDI
GMDN Term
Blood flowmeter transducer, non-indwelling FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.2120 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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

Category: Blood flowmeter transducer, non-indwelling

Bio-Probe® by Medtronic, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Blood flowmeter transducer, non-indwelling.

Cleared under the same submission

K830858 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medtronic, Inc.

Sources (1)

  • FDA UDI e20a837c-5f34-425b-aa90-d2cb3a4ea80e 37 fields · synced May 30, 2026