FDA UDI In Commercial Distribution 🇺🇸 United States

CO-Pilot™ Wireless Handheld Multi-Parameter System

DI: 00849686051056 · Model: H500-DK · NONIN MEDICAL, INC.
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
CO-Pilot™ Wireless Handheld Multi-Parameter System
Primary DI
00849686051056
Version / Model
H500-DK
Catalog Number
114082-001
Company Name
NONIN MEDICAL, INC.
Labeler DUNS
174959692
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-10-23
Public Version
2
Public Version Date
2021-11-10
Public Version Status
Update
Public Device Record Key
046501e9-a41d-4416-89c8-f6b4130eaec6

Device Description

Data Kit

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
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
45607 Pulse oximeter

Identifiers

Type ID
Primary 00849686051056