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Masimo Pulse Oximeter Probe

FDA UDI

Class II (US FDA UDI)

by Renu Medical, Inc

Identity

Trade Name
Masimo Pulse Oximeter Probe FDA UDI
Generic Name
Pulse oximeter probe, reprocessed FDA UDI
Device Name
LNCS Infant Probe FDA UDI
Model / Reference
RM-2329 FDA UDI
Description
LNCS Infant Probe FDA UDI

Identifiers

Primary DI / UDI-DI
00816317020507 FDA UDI
510(k) Number
K081927 FDA UDI
FDA Product Code
NLF FDA UDI
GMDN Term
Pulse oximeter probe, reprocessed FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.2700 FDA UDI
Commercial Distribution
Not 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

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Masimo Pulse Oximeter Probe by Renu Medical, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K081927 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Renu Medical, Inc

Sources (1)

  • FDA UDI 9394b943-3212-4b36-94be-25987ee65869 35 fields · synced Jun 6, 2026