IV Administration Set,Non-Toxic

GUDID 00840117335226

Sterile

DYNAREX CORPORATION

Intravenous administration tubing extension set
Primary Device ID00840117335226
NIH Device Record Key5485ceb9-3aa7-475a-abb4-7e4afd9e27bc
Commercial Distribution StatusIn Commercial Distribution
Brand NameIV Administration Set,Non-Toxic
Version Model Number7068
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 Batchfalse
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100840117335226 [Package]
Contains: 00840117335240
Package: MC [50 Units]
In Commercial Distribution
GS100840117335240 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FPASet, Administration, Intravascular

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-03-19
Device Publish Date2024-03-11

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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