FDA UDI In Commercial Distribution 🇺🇸 United States

3B Medical, Inc. Qube Compressor Nebulizer

DI: 00817783020251 · Model: QN1000 · 3B MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
3B Medical, Inc. Qube Compressor Nebulizer
Primary DI
00817783020251
Version / Model
QN1000
Company Name
3B MEDICAL, INC.
Labeler DUNS
078517316
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2017-10-13
Public Version
2
Public Version Date
2018-03-29
Public Version Status
Update
Public Device Record Key
a9d3422f-85a4-4355-a0b8-9cdf67cef640

Device Description

Nebulisers are devices used to deliver atomised particles of drug to the airways via compressed air

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
Yes
Has Manufacturing Date
Yes
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
12719 Ultrasonic nebulizing system

Identifiers

Type ID
Primary 00817783020251