FDA UDI In Commercial Distribution 🇺🇸 United States

AirView

DI: 00619498000845 · Model: 4.2 · RESMED PTY LTD
Product Codes
4
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
AirView
Primary DI
00619498000845
Version / Model
4.2
Company Name
RESMED PTY LTD
Labeler DUNS
751149311
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-11-04
Public Version
3
Public Version Date
2021-07-23
Public Version Status
Update
Public Device Record Key
ac07eb5f-7655-4948-ba13-792e6cc8bf9e

Device Description

AirView

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
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
MNS Ventilator, Continuous, Non-Life-Supporting
MNR Ventilatory Effort Recorder
BZD Ventilator, Non-Continuous (Respirator)
CBK Ventilator, Continuous, Facility Use

GMDN Terms

Code Name
40582 Ventilator application software

Identifiers

Type ID
Primary 00619498000845

Customer Contacts

Phone
800-427-0737