Model: DYNDH2338
Catalog: DYNDH2338
DI: 10653160393436
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-15
Current Version: 2026-05-25
Description
BLOOD CULTURE COLL KITS - PIV
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
43cd8ede-ddbb-4c88-8f3c-35c84dd0d27b
Distribution Status:
In Commercial Distribution
DUNS Number:
025460908
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
Yes
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:
CS
Item #1 - Device ID:
00653160393439
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
20
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
10653160393436
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
10653160393436
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 58496
Name: Blood collection set, noninvasive
Definition:
A collection of sterile, noninvasive devices intended to be used by a healthcare professional, in combination with evacuated blood collection tubes and a separate blood access device (e.g., intravenous catheter), for the routine collection of multiple blood specimens from a patient, for clinical analyses. It consists of various device combinations that may include tubing, male/female Luer-lock connectors, clamps, and a blood collection tube holder; the set may connect to, but does not contain, an invasive blood access device(s) [e.g., an intravenous catheter]. This is a single-patient device that may be reapplied over a short term (single-use) before being discarded.
FDA Product Codes
OIB
Blood and urine collection kit (excludes HIV testing)