Device
6935
Manufacturer
Dynarex Corporation
Model: 6935 DI: 00840117352230 Status: Update MRI: Labeling does not contain MRI Safety Information Single-use: Yes Rx: Yes OTC: No
First Published: 2021-05-21 Current Version: 2026-05-27
Sterilization
Device Sterile: Yes
Sterilization Prior To Use: No
Regulatory & Distribution
Record Status: Published
Version Number: 3
Record Key: 741cc70d-9bfc-4b96-8fd8-881ce1616d4b
Distribution Status: In Commercial Distribution
DUNS Number: 008124539
Device Count: 1
DM Exempt: No
Premarket Exempt: Yes
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 - Device ID: 00840117352230
Item #1 - Device ID Type: Primary
Item #1 - Device ID Issuing Agency: GS1
Item #2 - Pkg Type: Box
Item #2 - Device ID: 00840117352247
Item #2 - Pkg Status: In Commercial Distribution
Item #2 - Pkg Quantity: 200
Item #2 - Device ID Type: Package
Item #2 - Contains DINumber: 00840117352230
Item #2 - Device ID Issuing Agency: GS1
Item #3 - Pkg Type: Shipper
Item #3 - Device ID: 00840117352254
Item #3 - Pkg Status: In Commercial Distribution
Item #3 - Pkg Quantity: 4
Item #3 - Device ID Type: Package
Item #3 - Contains DINumber: 00840117352247
Item #3 - Device ID Issuing Agency: GS1
GMDN
Code: 37566
Name: Blood collection tube holder, single-use
Definition:
A hand-held cylindrical device designed to be used together with an evacuated blood collection tube to draw blood samples from a patient. It is typically a hollow plastic adaptor into which the blood collection tube is inserted and to which the user attaches a hypodermic blood collection needle (not included); it may include an integrated blood collection tube spike. This device also facilitates a multiple-tube blood collection via one venipuncture. This is a single-use device.
FDA Product Codes
KST
System, Blood Collection, Vacuum-Assisted, Manual