FDA UDI In Commercial Distribution 🇺🇸 United States

Good Sense

DI: 00846036007695 · Model: 69-50C · GEISS, DESTIN & DUNN, INC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1

Basic Information

Brand Name
Good Sense
Primary DI
00846036007695
Version / Model
69-50C
Company Name
GEISS, DESTIN & DUNN, INC
Labeler DUNS
076059836
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-23
Public Version
4
Public Version Date
2021-11-10
Public Version Status
Update
Public Device Record Key
8b7f1990-43da-4f75-80cd-19dcb6d753b2

Device Description

GoodSense Pulse Oximeter

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
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
DQA Oximeter

GMDN Terms

Code Name
37808 Pulse oximeter probe, reusable

Identifiers

Type ID
Package 10846036007692
Package 30846036007696
Primary 00846036007695

Customer Contacts

Premarket Submissions

Submission Number Supplement Number
K073454 000