Device
7054
Manufacturer
Dynarex Corporation
Model: 7054 DI: 00616784705415 Status: Update MRI: Labeling does not contain MRI Safety Information Single-use: Yes Rx: Yes OTC: No
First Published: 2016-09-24 Current Version: 2026-05-29
Sterilization
Device Sterile: Yes
Sterilization Prior To Use: No
Regulatory & Distribution
Record Status: Published
Version Number: 7
Record Key: 52f4d254-3c2c-4359-bbc9-f70a461391b0
Distribution Status: In Commercial Distribution
DUNS Number: 008124539
Device Count: 1
DM Exempt: No
Premarket Exempt: No
HCT/P: No
Kit: No
Combination Product: No
Lot/Batch Tracked: Yes
Serial Number Tracked: No
Manufacturing Date Tracked: Yes
Expiration Date Tracked: Yes
Donation ID Number Tracked: No
Labeled Contains NRL: No
Labeled No NRL: Yes
Identifiers
Item #1 - Pkg Type: Shipper
Item #1 - Device ID: 00616784705439
Item #1 - Pkg Status: In Commercial Distribution
Item #1 - Pkg Quantity: 24
Item #1 - Device ID Type: Package
Item #1 - Contains DINumber: 00616784705415
Item #1 - Device ID Issuing Agency: GS1
Item #2 - Device ID: 00616784705415
Item #2 - Device ID Type: Primary
Item #2 - Device ID Issuing Agency: GS1
Item #3 - Pkg Type: Box
Item #3 - Device ID: 00840117346840
Item #3 - Pkg Status: In Commercial Distribution
Item #3 - Pkg Quantity: 100
Item #3 - Device ID Type: Package
Item #3 - Contains DINumber: 00616784705439
Item #3 - Device ID Issuing Agency: GS1
GMDN
Code: 60538
Name: Luer/Luer linear connector, single-use
Definition:
A small, non-powered, noninvasive tubular, two-way/linear connector with a Luer connection (either lock or slip) at both ends intended to connect two luminal devices (e.g., catheter, tubing, container) with each other. It may have a straight or elbow shape; it does not incorporate a filter, valve, clamp, tubing nor puncturing component. This is a single-use device.
FDA Product Codes
LHI
Set, I.V. Fluid Transfer
FPA
Set, Administration, Intravascular