FDA UDI In Commercial Distribution 🇺🇸 United States

Para-Pak SpinCon (No Funnels)

DI: 00840733102639 · Model: 973500 · MERIDIAN BIOSCIENCE, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Para-Pak SpinCon (No Funnels)
Primary DI
00840733102639
Version / Model
973500
Catalog Number
973500
Company Name
MERIDIAN BIOSCIENCE, INC.
Labeler DUNS
092815364
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-12-09
Public Version
1
Public Version Date
2020-12-17
Public Version Status
New
Public Device Record Key
227364f7-c72d-4aa8-a8f5-745a35abb3be

Device Description

Para-Pak SpinCon is a unique patented system for the concentration of parasite eggs, larvae, and protozoa from preserved fecal specimens.

Device Characteristics

Single Use
Yes
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
No
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
LKS Device, Parasite Concentration

GMDN Terms

Code Name
63816 Faecal parasite isolation kit IVD

Identifiers

Type ID
Primary 00840733102639

Customer Contacts

Phone
513-271-3700

Storage Conditions

Type
Storage Environment Temperature
Temperature Range
15 – 30 Degrees Celsius