FDA.reportPublic FDA data

42 in(107cm) Extension Set w/ 2 check valves

Primary DI
00634624092198
Brand
42 in(107cm) Extension Set w/ 2 check valves
Company
QUEST MEDICAL INC
Model
9219
Catalog number
9219
Published
2016-07-26
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
FPKTubing, Fluid Delivery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPKTubing, Fluid DeliveryGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K800825000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K800825000EXTENSION SET QUEST CODE #3000Quest Medical, Inc.1980-05-14FPK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00634624092198PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00634624092198006346240921986346240921980634624092198

GMDN Terms#

Term, Definition table
TermDefinition
Intravenous administration tubing extension setA collection of tubing and connectors intended to establish an extension of tubing where the standard length of the tubing in an intravenous (IV) administration set is insufficient. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
041810693
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

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Primary DI, Brand, Model table
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00634624031500Q2® Needleless injection site 315031502017-03-09
20634624100606Qlinch Securement BandQSB00602020-04-08
20634624530380MPS 3 ISO Medical Air Hose Kit5303010-CA2023-10-16
00634624096523Checkmate IV Administration Set 123in (312 cm)965296522016-07-29
20634624530397MPS 3 Drug Pump Cover53030312023-03-24
00634624911109Precision Delivery Bifurcated IV Extension SetPDBV05F2022-12-19
00634624911048High-Flow Extension SetHF01352022-12-12
00634624101159Q2 IV Administration SetASV101152022-12-06
00634624101258Q2 IV Administration SetASV101252022-12-06
00634624101302Q2 IV Administration SetASV101302022-12-06
00634624601253Q2 IV Administration SetASV601252022-12-06
00634624921092High-Flow 4-Way StopcockSTV022022-12-06
00634624921108High-Flow 4-Way StopcockSTV032022-12-06
00634624921160High-Flow 4-Way StopcockST012022-12-06
00634624921191High-Flow 4-Way StopcockST032022-12-06
00634624921207Q2 Blood Administration SetYV1152022-12-06
00634624921214Q2 Blood Administration SetYV1302022-12-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10884450628307Merit Medical®ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.FPK2024-12-07
10192253003338MonojectCardinal Health 200, LLCFPK2024-08-21
10192253003345MonojectCardinal Health 200, LLCFPK2024-08-21
10192253003352MonojectCardinal Health 200, LLCFPK2024-08-21
00616258024554Swabbable Valve Transfer SetBayer Medical Care Inc.FPK2024-05-06
00616258024561MEDRAD® Twist & Go Disposable Syringe 150mL with Quick Fill TubeBayer Medical Care Inc.FPK2024-05-06
00616258024820MEDRAD® Twist & Go Disposable Syringe 150mL with Quick Fill TubeBayer Medical Care Inc.FPK2024-05-06
10884450325312Merit Medical®ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.FPK2021-04-05
00849884005141VYGONVygon CorporationFPK2021-01-28
10849884002260VYGONVygon CorporationFPK2020-06-02
00849884002720VYGONVygon CorporationFPK2020-06-01
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10849884002666VYGONVygon CorporationFPK2020-04-02
10849884002765VYGONVygon CorporationFPK2020-04-02
10849884002581VYGONVygon CorporationFPK2020-04-01
00849884004441VYGONVygon CorporationFPK2020-03-12
00849884003956VYGONVygon CorporationFPK2020-01-28
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10351688507112MedexICU MEDICAL, INC.FPK2020-01-13
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00849884000559VYGONVygon CorporationFPK2019-12-16
00849884000566VYGONVygon CorporationFPK2019-12-16
00634624957817Exoflex 10.5in. IVExtension Set QUEST MEDICAL INCFPK2019-12-09
00849884000269VYGONVygon CorporationFPK2019-11-14
00849884000313VYGONVygon CorporationFPK2019-11-14
00849884000375VYGONVygon CorporationFPK2019-11-14
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