FDA UDI In Commercial Distribution 🇺🇸 United States

CoughAssist

DI: 00606959058477 · Model: Cough Assist E70, FR · Respironics, Inc.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
CoughAssist
Primary DI
00606959058477
Version / Model
Cough Assist E70, FR
Catalog Number
FR1098159
Company Name
Respironics, Inc.
Labeler DUNS
080728314
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-09-23
Public Version
3
Public Version Date
2021-06-22
Public Version Status
Update
Public Device Record Key
0e2b7bb2-c355-45fb-9dd2-3fa4178d6d37

Device Description

Cough Assist E70, FR

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
Yes
Has Lot/Batch Number
No
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
BYI PERCUSSOR, POWERED-ELECTRIC
NHJ DEVICE, POSITIVE PRESSURE BREATHING, INTERMITTENT

GMDN Terms

Code Name
43947 Positive pressure airway secretion-clearing device

Identifiers

Type ID
Primary 00606959058477