FDA UDI In Commercial Distribution 🇺🇸 United States

Wash1 Kit

DI: 00386100001858 · Model: 10680 · MEDICA CORPORATION
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Wash1 Kit
Primary DI
00386100001858
Version / Model
10680
Catalog Number
10680
Company Name
MEDICA CORPORATION
Labeler DUNS
112942404
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2019-02-21
Public Version
1
Public Version Date
2019-03-11
Public Version Status
New
Public Device Record Key
ef7db530-f7ce-47c0-a8bc-66599e7ef73e

Device Description

Wash1 Kit for use with EasyRA Analyzers

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
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
Yes
Has Serial Number
No
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

GMDN Terms

Code Name
59058 Wash/cleaning solution IVD, automated/semi-automated system

Identifiers

Type ID
Primary 00386100001858

Customer Contacts

Phone
781-275-4892

Storage Conditions

Type
Storage Environment Temperature
Temperature Range
2 – 25 Degrees Celsius