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Threshold

FDA UDI

Class II (US FDA UDI)

by Respironics Respiratory Drug Delivery (uk) Ltd

Identity

Trade Name
THRESHOLD FDA UDI
Generic Name
Incentive spirometer FDA UDI
Device Name
Threshold IMT (730EU) Single Unit. FDA UDI
Model / Reference
0 FDA UDI
Description
Threshold IMT (730EU) Single Unit. FDA UDI

Identifiers

Catalog Number
HS730EU-001 FDA UDI
Primary DI / UDI-DI
00383730001029 FDA UDI
FDA Product Code
BWF FDA UDI
GMDN Term
Incentive spirometer FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.5690 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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Incentive spirometer

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

Similar devices

Also classified as Incentive spirometer.

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 178b51df-e97d-4c52-bc7f-eca8b68c8abd 35 fields · synced May 30, 2026