FDA.reportPublic FDA data

Orion II

Primary DI
00876604002012
Brand
Orion II
Company
Health Line International Corporation
Model
A33-05130
Device description
16Ga x 30 cm Single Lumen Orion II CT CVC Kit
Published
2018-01-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FOZCatheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 DaysGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10876604002019PackageGS15In Commercial Distribution
20876604002016PackageGS14In Commercial Distribution
00876604002012PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1087660400201910876604002019
2087660400201620876604002016
00876604002012008766040020128766040020120876604002012

GMDN Terms#

Term, Definition table
TermDefinition
Central venous catheterization kit, short-termA collection of devices and materials intended for the short-term (<= 30 days) introduction of a central venous catheter (CVC) for various infusion/aspiration procedures (i.e., non-dedicated). Often referred to as tray, it includes a nonimplantable central venous catheter with devices dedicated to catheter introduction/function (e.g., introducer, guidewire), and non-dedicated supportive devices (e.g., drape, dressings, scalpel). This is a single-use device.

Regulatory Flags#

DUNS number
806251398
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00876604004603Synergy-XSA14-03160-03A14-031602023-05-24
00876604004627Synergy-XSA14-04260-03A14-042602023-05-24
00876604004634SynergyA14-05160-03A14-051602023-05-24
00876604004641SynergyA14-05260-03A14-052602023-05-24
00876604004658SynergyA14-06260-03A14-062602023-05-24
00876604004665SynergyA14-06360-03A14-063602023-05-24
00876604004672Synergy-XSA14-03160-N-03A14-03160-N2023-05-24
00876604004689Synergy-XSA14-04260-N-03A14-04260-N2023-05-24
00876604004696SynergyA14-05160-N-03A14-05160-N2023-05-24
00876604004702SynergyA14-06260-N-03A14-06260-N2023-05-24
00876604004719SynergyA14-06360-N-03A14-06360-N2023-05-24
00876604004726SynergyA14-05260-N-03A14-05260-N2023-05-24
00876604004733SynergyA14-04160-N-03A14-04160-N2023-05-24
00876604004740Synergy-XSA14-03160-IR-03A14-03160-IR2023-05-24
00876604004757SynergyA14-04160-IR-03A14-04160-IR2023-05-24
00876604004764Synergy-XSA14-04260-IR-03A14-04260-IR2023-05-24
00876604004788SynergyA14-05260-IR-03A14-05260-IR2023-05-24
00876604004795SynergyA14-06260-IR-03A14-06260-IR2023-05-24
00876604004801SynergyA14-06360-IR-03A14-06360-IR2023-05-24
10876604004600Synergy-XSA14-03160-03A14-031602023-05-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10801902226379ARROWTELEFLEX INCORPORATEDFOZ2026-07-14
10801902226386ARROWTELEFLEX INCORPORATEDFOZ2026-07-14
00850073657003Ruby Intravascular CatheterVenocare, Inc.FOZ2026-04-08
08032248007123SOL CARE T DELTA MED SPAFOZ2021-03-30
08032248007130SOL CARE T DELTA MED SPAFOZ2021-03-30
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08032248007246SOL CARE 1DELTA MED SPAFOZ2021-03-30
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08032248007260SOL CARE 1DELTA MED SPAFOZ2021-03-30
08032248007277SOL CARE 1DELTA MED SPAFOZ2021-03-30
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08032248007291SOL CARE 1DELTA MED SPAFOZ2021-03-30
08032248005372Deltaven Fast FlashDELTA MED SPAFOZ2020-10-26
08032248005389Deltaven Fast FlashDELTA MED SPAFOZ2020-10-26
08032248005396Deltaven Fast FlashDELTA MED SPAFOZ2020-10-26
08032248005402Deltaven Fast FlashDELTA MED SPAFOZ2020-10-26
08032248005419Deltaven Fast FlashDELTA MED SPAFOZ2020-10-26
08032248005426Deltaven Fast FlashDELTA MED SPAFOZ2020-10-26
08032248005433Deltaven Fast FlashDELTA MED SPAFOZ2020-10-26
08032248005440Deltaven Fast FlashDELTA MED SPAFOZ2020-10-26
08032248005457Deltaven Fast FlashDELTA MED SPAFOZ2020-10-26