FDA UDI In Commercial Distribution 🇺🇸 United States

Carex Health Brands

DI: 00023601064165 · Model: FGR41600 0000 · COMPASS HEALTH BRANDS CORP.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
Carex Health Brands
Primary DI
00023601064165
Version / Model
FGR41600 0000
Company Name
COMPASS HEALTH BRANDS CORP.
Labeler DUNS
827221698
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-10-07
Public Version
3
Public Version Date
2023-09-13
Public Version Status
Update
Public Device Record Key
370aab30-e473-40c0-b1c9-0140c276f5be

Device Description

Adult Nebulizer Kit w/ Mask

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
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
CAF Nebulizer (Direct Patient Interface)

GMDN Terms

Code Name
66295 Ambulatory nebulizer, non-heated

Identifiers

Type ID
Package 30023601064166
Primary 00023601064165

Customer Contacts

Phone
800-376-7263