IV Adminiatrstion Set

GUDID 00616784704029

DYNAREX CORPORATION

Intravenous administration set
Primary Device ID00616784704029
NIH Device Record Keydda7c154-538b-4f78-8533-98bb53a82853
Commercial Distribution StatusIn Commercial Distribution
Brand NameIV Adminiatrstion Set
Version Model Number7040
Company DUNS008124539
Company NameDYNAREX CORPORATION
Device Count1
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 Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100616784704029 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FPASet, Administration, Intravascular

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-12-11
Device Publish Date2018-01-06

Devices Manufactured by DYNAREX CORPORATION

00810180840163 - DynaSafety Cotton-Tipped Applicators in Sealed Vial,3"2024-11-19
00840117341210 - Medicine Cups 1oz 2024-11-05
00840117312906 - Resp-O2 Endotracheal Tube Cuffed, 4.0 mm 2024-11-01 Sterile-EO
00840117312920 - Resp-O2 Endotracheal Tube Cuffed, 4.5 mm 2024-11-01 Sterile-EO
00840117317475 - Resp-O2 Endotracheal Tube Cuffed, 5.0 mm 2024-11-01 Sterile-EO
00840117312968 - Resp-O2 Endotracheal Tube Cuffed, 5.5 mm 2024-11-01 Sterile-Eo
00840117312982 - Resp-O2 Endotracheal Tube Cuffed, 6.0 mm 2024-11-01 Sterile-Eo
00840117313002 - Resp-O2 Endotracheal Tube Cuffed, 6.5 mm2024-11-01 Sterile-Eo

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