FDA UDI Not in Commercial Distribution 🇺🇸 United States

Ultraview

DI: 10841522102752 · Model: 90478 · SPACELABS HEALTHCARE (WASHINGTON), INC
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Ultraview
Primary DI
10841522102752
Version / Model
90478
Catalog Number
3.05.07EN
Company Name
SPACELABS HEALTHCARE (WASHINGTON), INC
Labeler DUNS
145581588
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2018-03-12
Public Version
3
Public Version Date
2022-11-28
Public Version Status
Update
Public Device Record Key
ca263368-0f9b-4ab3-aae2-bbc9e540c257
Distribution End Date
2018-03-14

Device Description

KIT,TM MOD,MV0 TO MV2 ST

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
Yes
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

GMDN Terms

Code Name
36365 Electrocardiography monitoring system receiver

Identifiers

Type ID
Primary 10841522102752

Storage Conditions

Type
Storage Environment Humidity
Temperature Range
0 – 0 Percent (%) Relative Humidity
Type
Storage Environment Temperature
Temperature Range
0 – 0 Degrees Celsius