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Oval Mouthpiece

FDA UDI

Class II (US FDA UDI)

by Respironics Respiratory Drug Delivery (uk) Ltd

Identity

Trade Name
OVAL MOUTHPIECE FDA UDI
Generic Name
Peak flow meter, manual FDA UDI
Device Name
OVAL MOUTHPIECE FDA UDI
Model / Reference
1136960 FDA UDI
Description
OVAL MOUTHPIECE FDA UDI

Identifiers

Catalog Number
1136960 FDA UDI
Primary DI / UDI-DI
00383730004648 FDA UDI
FDA Product Code
BZH FDA UDI
GMDN Term
Peak flow meter, manual FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.1860 FDA UDI
Commercial Distribution
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

No

FDA UDI

Over-the-Counter

Yes

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

Yes

FDA UDI

Category: Peak flow meter, manual

Oval Mouthpiece by Respironics Respiratory Drug Delivery (uk) Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Peak flow meter, manual.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Respironics Respiratory Drug Delivery (uk) Ltd

Sources (1)

  • FDA UDI b9376750-60bd-4203-8759-378f9c8e8951 34 fields · synced May 30, 2026