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CoughAssist

FDA UDI

Class II (US FDA UDI)

by Respironics, Inc.

Identity

Trade Name
CoughAssist FDA UDI
Generic Name
Positive pressure airway secretion-clearing device FDA UDI
Device Name
Cough Assist E70, FR FDA UDI
Model / Reference
Cough Assist E70, FR FDA UDI
Description
Cough Assist E70, FR FDA UDI

Identifiers

Catalog Number
FR1098159 FDA UDI
Primary DI / UDI-DI
00606959058477 FDA UDI
FDA Product Code
BYI FDA UDI
NHJ FDA UDI
GMDN Term
Positive pressure airway secretion-clearing device FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.5665 FDA UDI
868.5905 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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Positive pressure airway secretion-clearing device

CoughAssist by Respironics, Inc. — 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, Inc.

Sources (1)

  • FDA UDI 0e2b7bb2-c355-45fb-9dd2-3fa4178d6d37 34 fields · synced May 31, 2026