FDA UDI In Commercial Distribution 🇺🇸 United States

S/W SUB VF7.0 GATEWAY

DI: 04049098059749 · Model: MS32681 · DRAEGER MEDICAL SYSTEMS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
S/W SUB VF7.0 GATEWAY
Primary DI
04049098059749
Version / Model
MS32681
Company Name
DRAEGER MEDICAL SYSTEMS, INC.
Labeler DUNS
788289952
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2017-07-12
Public Version
3
Public Version Date
2018-07-06
Public Version Status
Update
Public Device Record Key
1107f1fc-17ec-42d6-8166-ad0841f5e511

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
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
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

GMDN Terms

Code Name
44101 Bedside information system application software

Identifiers

Type ID
Primary 04049098059749

Customer Contacts

Phone
+18004372437

Premarket Submissions

Submission Number Supplement Number
K043549 000