FDA.reportPublic FDA data

Swabbable Valve Transfer Set

Primary DI
00616258024554
Brand
Swabbable Valve Transfer Set
Company
Bayer Medical Care Inc.
Model
SVTS
Catalog number
SVTS
Device description
ASSY,TBG,SWAB VALV,TNSFR SET,MC,CORE (87622584)
Published
2024-05-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true

Contact Domains#

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
K031808000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K031808000MEDRAD SWABBABLE VALVE TRANSFER SETMedrad, Inc.2003-07-11FPK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40616258024552PackageGS150In Commercial Distribution
00616258024554PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
4061625802455240616258024552
00616258024554006162580245546162580245540616258024554

GMDN Terms#

Term, Definition table
TermDefinition
Fluid transfer set, general-purposeA collection of devices and supplies designed to transfer several types of medical fluids (e.g., drugs, vaccines, blood, and solutions) between a first container(s) [e.g., a vial(s)] and a second container [e.g., an intravenous (IV) bag]; it is not dedicated to a particular type of fluid or clinical procedure. It is available in a variety of configurations and typically includes tubes, connectors, spike(s), syringes, and caps. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity0 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature-20 Degrees Celsius60 Degrees Celsius
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Celsius40 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1 800-633-7231ricustomercomplaints@bayer.com

Regulatory Flags#

DUNS number
049673973
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00616258007243200mL Sterile Disposable Qwik-Fit Syringe & QFT200-FLS-Q200-FLS-Q2016-09-24
00616258007526200mL Sterile Disposable Qwik-Fit Syringe & QFT200-FLS-Q200-FLS-Q2016-09-24
00616258024325MEDRAD® MRXperion Sterile Disposable MRI KitXP 65/115VSXP 65/115VS2024-05-06
00616258027340Imaging System Interface - ISI2 ModuleISI2ISI22024-06-17
00616258025094MEDRAD® MRXperion MR Injection SystemMRXP 200MRXP 2002024-05-06
00616258026206MEDRAD® MRXperion MR Injection System HandswitchSSMR STARTSSMR START2022-04-22
00616258010090200mL Sterile Disposable Qwik-Fit Syringe & QFT 200-FLS-Q 200-FLS-Q 2019-05-20
00616258005492200mL Sterile Disposable Qwik-Fit Syringe & QFT200-FLS-Q200-FLS-Q2016-09-24
00616258008165MEDRAD® MRXperion MR Injection SystemSSMR STARTSSMR START2016-09-24
00616258008943MEDRAD® Stellant CT Injection SystemStellant D-CESCT-310, SCT-321, SCT-3222016-09-24
00616258021249MEDRAD® VFLOW Sterile Disposable Hand ControllerVF HCVF HC2025-12-19
00616258020419MEDRAD® Mark 7 Arterion Injection SystemARTERION BASE SYSTEMARTERION BASE SYSTEM2025-12-19
40616258021247MEDRAD® VFLOW Sterile Disposable Hand ControllerVF HCVF HC2025-12-19
00616258025186MEDRAD® Stellant CT Injection SystemSCT-310, SCT-321, SCT-322SCT-310, SCT-321, SCT-3222025-12-10
00616258027333MEDRAD® Stellant FLEX CT Injection System with Certegra® WorkstationFLEXFLEX2025-12-10
00616258025131MEDRAD® Stellant CT Injection SystemSCT-310, SCT-321, SCT-322SCT-310, SCT-321, SCT-3222024-11-01
00616258010229Avanta Hand Controller SheathAVA 500 HCSAVA 500 HCS2019-05-20
00616258010236Display Control Unit Sheath AVA 500 DCOV AVA 500 DCOV 2019-05-20
00616258021546Avanta Hand Controller SheathAVA 500 HCSAVA 500 HCS2019-10-25
00616258021553Display Control Unit Sheath AVA 500 DCOV AVA 500 DCOV 2019-10-25

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10192253003352MonojectCardinal Health 200, LLCFPK2024-08-21
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
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00634624957817Exoflex 10.5in. IVExtension Set QUEST MEDICAL INCFPK2019-12-09
00849884000269VYGONVygon CorporationFPK2019-11-14
00849884000313VYGONVygon CorporationFPK2019-11-14
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