FDA UDI In Commercial Distribution 🇺🇸 United States

CHRONO-PAR

DI: 00811476010079 · Model: 395 · CHRONO-LOG CORP
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
CHRONO-PAR
Primary DI
00811476010079
Version / Model
395
Company Name
CHRONO-LOG CORP
Labeler DUNS
002353696
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-10-11
Public Version
2
Public Version Date
2018-03-29
Public Version Status
Update
Public Device Record Key
6017e73a-297e-4000-98f1-52e1678747d4

Device Description

CHRONO-LUME

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
No
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
56092 Platelet aggregation study IVD, reagent

Identifiers

Type ID
Primary 00811476010079

Customer Contacts

Phone
610-853-1130

Storage Conditions

Type
Storage Environment Temperature
Temperature Range
– 0 Degrees Celsius