FDA UDI In Commercial Distribution 🇺🇸 United States

RMDpulse

DI: 00840193400030 · Model: 22253 · RESMED CORP.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
RMDpulse
Primary DI
00840193400030
Version / Model
22253
Company Name
RESMED CORP.
Labeler DUNS
080243150
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2021-04-13
Public Version
2
Public Version Date
2021-07-29
Public Version Status
Update
Public Device Record Key
86189fd7-0205-4d90-be68-bfc0311f8d8a

Device Description

RMDpulse (iOS)

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
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
BZD Ventilator, Non-Continuous (Respirator)

GMDN Terms

Code Name
40582 Ventilator application software

Identifiers

Type ID
Primary 00840193400030

Customer Contacts

Phone
800-424-0737