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Ultraflow

FDA UDI

Class II (US FDA UDI)

by Advantage Medical Electronics, LLC

Identity

Trade Name
ULTRAFLOW FDA UDI
Generic Name
Patient monitoring system module, electrocardiographic/respiratory FDA UDI
Device Name
REUSABLE ULTRAFLOW RESPIRATION MONITOR: LARGE, SINGLE CHANNEL (2 PLUGS, 1 CHANNEL), 1 ORAL & 2 NASAL RECORDING POINTS FDA UDI
Model / Reference
SM-603700 FDA UDI
Description
REUSABLE ULTRAFLOW RESPIRATION MONITOR: LARGE, SINGLE CHANNEL (2 PLUGS, 1 CHANNEL), 1 ORAL & 2 NASAL RECORDING POINTS FDA UDI

Identifiers

Primary DI / UDI-DI
00849593015615 FDA UDI
FDA Product Code
BZQ FDA UDI
GMDN Term
Patient monitoring system module, electrocardiographic/respiratory FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.2375 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

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Patient monitoring system module, electrocardiographic/respiratory

Ultraflow by Advantage Medical Electronics, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Patient monitoring system module, electrocardiographic/respiratory.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Advantage Medical Electronics, LLC

Sources (1)

  • FDA UDI 725d3b00-4b24-4496-a19a-ed398a1d9e3d 34 fields · synced May 31, 2026