Needless PRN Connector

GUDID 00616784705439

DYNAREX CORPORATION

Luer/Luer linear connector, single-use
Primary Device ID00616784705439
NIH Device Record Key52f4d254-3c2c-4359-bbc9-f70a461391b0
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeedless PRN Connector
Version Model Number7054
Company DUNS008124539
Company NameDYNAREX CORPORATION
Device Count100
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100616784705415 [Unit of Use]
GS100616784705422 [Primary]
GS100616784705439 [Package]
Contains: 00616784705422
Package: [24 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LHISet, I.V. Fluid Transfer

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-10-23
Device Publish Date2016-09-24

Devices Manufactured by DYNAREX CORPORATION

00810180843331 - Durma+ DynaRule Disposable Paper Rulers2026-04-01
00810180845106 - Cotton Tipped Wood Applicators, Sterile2026-03-30 Cotton Tipped Wood Applicators, Sterile, 6", 1 per pouch
00810180845113 - Cotton Tipped Wood Applicators, Sterile2026-03-30 Cotton Tipped Wood Applicators, Sterile, 6", 2 per Pouch
00810180840712 - CurPro Dermal Curettes,2 mm 2026-03-27 Sterile-R
00840117347892 - Medi-Cut Safety Scalpel2026-03-27 Medi-Cut Safety Scalpel, Sterile, # 15
00810180844901 - Disposable Prep Razors2026-03-25 Disposable Prep Razors
00810180844918 - Medicine Cups 1oz 2026-03-25
00810180844925 - LabChoice Specimen Container, Screw-On, Leak-Resistant Lid, Tamper-Ever Seal 2026-03-25 Sterile-EO

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.