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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
Positive pressure airway secretion-clearing device FDA UDI
Device Name
Threshold PEP (735), 10 pack. FDA UDI
Model / Reference
00 FDA UDI
Description
Threshold PEP (735), 10 pack. FDA UDI

Identifiers

Catalog Number
HS735-010 FDA UDI
Primary DI / UDI-DI
00383730001036 FDA UDI
FDA Product Code
BWF FDA UDI
GMDN Term
Positive pressure airway secretion-clearing device 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: Positive pressure airway secretion-clearing device

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 Positive pressure airway secretion-clearing device.

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 b40477e4-93f1-4e0c-8c96-a5026197bf17 35 fields · synced May 30, 2026