Model: DYNDH2339
Catalog: DYNDH2339
DI: 10653160393368
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-08
Current Version: 2026-05-18
Description
CENTRAL LINE BCK WITHOUT BOTTLES
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
1da7a634-1102-400e-b13d-73ffd3656f0e
Distribution Status:
In Commercial Distribution
DUNS Number:
025460908
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
Yes
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:
No
Labeled No NRL:
Yes
Identifiers
Item #1 - Pkg Type:
CS
Item #1 - Device ID:
00653160393361
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
20
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
10653160393368
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
10653160393368
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)