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Teledyne Analytical Instruments

FDA UDI

Class II (US FDA UDI)

by Teledyne Analytical Instrs

Identity

Trade Name
Teledyne Analytical Instruments FDA UDI
Generic Name
Respiratory oxygen sensor FDA UDI
Device Name
Oxygen Sensor FDA UDI
Model / Reference
R15 FDA UDI
Description
Oxygen Sensor FDA UDI

Identifiers

Primary DI / UDI-DI
00852470008044 FDA UDI
510(k) Number
K001095 FDA UDI
FDA Product Code
CCL FDA UDI
GMDN Term
Respiratory oxygen sensor FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.1720 FDA UDI
Commercial Distribution
Not 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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Teledyne Analytical Instruments by Teledyne Analytical Instrs — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K001095 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Teledyne Analytical Instrs

Sources (1)

  • FDA UDI 4ff81791-4642-4092-a079-9e1e21ffbd70 35 fields · synced Jun 8, 2026