FDA UDI In Commercial Distribution 🇺🇸 United States

Diluent for Urine

DI: 04580262010345 · Model: 20-27-0482 · TOKYO BOEKI MEDISYS INC.
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
Diluent for Urine
Primary DI
04580262010345
Version / Model
20-27-0482
Catalog Number
20-27-0482
Company Name
TOKYO BOEKI MEDISYS INC.
Labeler DUNS
696265656
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2019-09-30
Public Version
8
Public Version Date
2024-02-05
Public Version Status
Update
Public Device Record Key
c6155d6c-ee9f-47a1-9be7-36a668ac9906

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
Yes
Has Manufacturing Date
No
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

GMDN Terms

Code Name
58237 Buffered sample diluent IVD

Identifiers

Type ID
Primary 04580262010345

Customer Contacts

Phone
+81425872965

Storage Conditions

Type
Storage Environment Temperature
Temperature Range
10 – 30 Degrees Celsius