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Infinity Nellcor Mount Kit

FDA UDI

Class II (US FDA UDI)

by Draeger Medical Systems, Inc.

Identity

Trade Name
INFINITY NELLCOR MOUNT KIT FDA UDI
Generic Name
Patient monitoring system module, pulse oximetry FDA UDI
Model / Reference
MS28963 FDA UDI

Identifiers

Primary DI / UDI-DI
04049098047838 FDA UDI
FDA Product Code
DQA FDA UDI
MHX FDA UDI
GMDN Term
Patient monitoring system module, pulse oximetry FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.2700 FDA UDI
870.1025 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Patient monitoring system module, pulse oximetry

Infinity Nellcor Mount Kit by Draeger Medical Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Patient monitoring system module, pulse oximetry.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Draeger Medical Systems, Inc.

Sources (1)

  • FDA UDI eb9ce8ec-8ae2-4577-9f2a-1341afecc8f8 33 fields · synced Jun 9, 2026