FDA UDI In Commercial Distribution 🇺🇸 United States

SENTINEL

DI: 10841522130922 · Model: 98200 · SPACELABS HEALTHCARE (WASHINGTON), INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
SENTINEL
Primary DI
10841522130922
Version / Model
98200
Catalog Number
040-1724-01
Company Name
SPACELABS HEALTHCARE (WASHINGTON), INC
Labeler DUNS
145581588
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-04-13
Public Version
1
Public Version Date
2023-04-21
Public Version Status
New
Public Device Record Key
2bc50629-d2b7-4fa1-adf7-fbffd7ee2368

Device Description

SENTINEL 11 HL7 TEST SYSTEM

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
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
DQK Computer, diagnostic, programmable

GMDN Terms

Code Name
44098 Cardiology information system application software

Identifiers

Type ID
Primary 10841522130922