FDA UDI In Commercial Distribution 🇺🇸 United States

PM 25 V3 U F KP

DI: B800PM25V3UFKP0 · Model: PM 25 V3 U F KP · UTAK LABORATORIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
PM 25 V3 U F KP
Primary DI
B800PM25V3UFKP0
Version / Model
PM 25 V3 U F KP
Catalog Number
PM 25 V3 U F KP
Company Name
UTAK LABORATORIES, INC.
Labeler DUNS
092519016
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2025-01-25
Public Version
1
Public Version Date
2025-02-03
Public Version Status
New
Public Device Record Key
675931a1-b87a-4d4f-a348-950f092dd676

Device Description

PM 25 V3 U F KP

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

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
LAS Drug Specific Control Materials

GMDN Terms

Code Name
47869 Multiple-type clinical chemistry analyte profile IVD, control

Identifiers

Type ID
Package B800PM25V3UFKP5
Primary B800PM25V3UFKP0

Customer Contacts

Device Sizes

Type Value Unit Text
Total Volume 2 Milliliter

Storage Conditions

Type
Storage Environment Temperature
Temperature Range
– -10 Degrees Celsius