FDA UDI In Commercial Distribution 🇺🇸 United States

Zyno Solutions

DI: 00862492000308 · Model: Pump Nimbus II Plus · OPTUMHEALTH CARE SOLUTIONS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Zyno Solutions
Primary DI
00862492000308
Version / Model
Pump Nimbus II Plus
Catalog Number
AAA-00170
Company Name
OPTUMHEALTH CARE SOLUTIONS, INC.
Labeler DUNS
078270206
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-12-07
Public Version
4
Public Version Date
2023-08-18
Public Version Status
Update
Public Device Record Key
cb3da3a2-6829-4887-9fd6-c2fa5982a168

Device Description

Nimbus II-Optum Homecare Infusion

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
Yes
PM Exempt
Yes
Has Serial Number
Yes
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
FRN Pump, infusion

GMDN Terms

Code Name
61514 Ambulatory non-insulin infusion pump, electronic

Identifiers

Type ID
Primary 00862492000308