Model: K745M-5
DI: B085K745M50
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-04-30
Current Version: 2026-05-08
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
242b36f3-66b5-4481-98b2-42ea20663561
Distribution Status:
In Commercial Distribution
DUNS Number:
077974989
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
Yes
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
B085K745M50
Type:
Primary
Issuing Agency:
HIBCC
GMDN
Code: 52886
Name: Osmolality IVD, control
Definition:
A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of osmolality of a clinical specimen.
FDA Product Codes
None