FDA UDI In Commercial Distribution 🇺🇸 United States

Hopkins Medical Products®

DI: 00817643020384 · Model: 599590-BK · HOPKINS UNIFORM COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Hopkins Medical Products®
Primary DI
00817643020384
Version / Model
599590-BK
Catalog Number
599590-BK
Company Name
HOPKINS UNIFORM COMPANY
Labeler DUNS
003080678
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2018-09-28
Public Version
2
Public Version Date
2021-11-10
Public Version Status
Update
Public Device Record Key
224ea42d-84aa-4ff8-ac55-aa170d79535b

Device Description

Onyx Vantage Pulse Ox- Black

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
No
Has Lot/Batch Number
No
Has Manufacturing Date
Yes
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
Primary 00817643020384

Customer Contacts