FDA UDI In Commercial Distribution 🇺🇸 United States

NOVA

DI: 06945040104353 · Model: PO-301 · Contec Medical Systems Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1

Basic Information

Brand Name
NOVA
Primary DI
06945040104353
Version / Model
PO-301
Company Name
Contec Medical Systems Co., Ltd.
Labeler DUNS
529606295
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2017-06-07
Public Version
3
Public Version Date
2021-11-10
Public Version Status
Update
Public Device Record Key
123f3473-7fd4-4bda-8ed7-7d95437d843c

Device Description

Pulse Oximeter

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
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
Yes
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

Product Codes

Code Name
DQA Oximeter

GMDN Terms

Code Name
45607 Pulse oximeter

Identifiers

Type ID
Package 26945040104357
Package 16945040104350
Primary 06945040104353