Model: CA64350
Catalog: CA64350
DI: 10885380211768
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: Yes
First Published: 2026-05-06
Current Version: 2026-05-14
Description
Kit Adult Blood Culture for Lifepoint Health Only
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
12da195d-49b1-4c9d-99c0-9fd33ffa9bdf
Distribution Status:
In Commercial Distribution
DUNS Number:
194550042
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:
Yes
Labeled No NRL:
No
Identifiers
Item #1 - Pkg Type:
CASE
Item #1 - Device ID:
50885380211766
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
50
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
10885380211768
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
10885380211768
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 18026
Name: Phlebotomy kit
Definition:
A collection of devices and supplies used in the practice of collecting blood samples. It typically consists of test tubes, racks, needles, bandages, gauze pads, and a sharps container. This is a single-use device.
FDA Product Codes
OIB
Blood and urine collection kit (excludes HIV testing)
Environmental Conditions
Storage Handling - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Storage Handling - Storage Handling Low - @attributes - Value:
15
Storage Handling - Storage Handling High - @attributes - Unit:
Degrees Celsius
Storage Handling - Storage Handling High - @attributes - Value:
25
Storage Handling - Storage Handling Type:
Storage Environment Temperature