FDA.reportPublic FDA data

MEDRAD® Twist & Go Disposable Syringe 150mL with Quick Fill Tube

Primary DI
40616258024828
Brand
MEDRAD® Twist & Go Disposable Syringe 150mL with Quick Fill Tube
Company
Bayer Medical Care Inc.
Model
TAG 150 SYR
Catalog number
TAG 150 SYR
Device description
TAG,KIT,SYR,ANGIO,150ML,MC,CORE2 (87622797)
Published
2024-05-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
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
K131517000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131517000MEDRAD TWIST & GO HIGH PRESSURE CONNECTOR TUBINGMedrad, Inc. / Bayer Medical Care, Inc.2013-08-02FPK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40616258024828PackageGS125In Commercial Distribution
00616258024820PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
4061625802482840616258024828
00616258024820006162580248206162580248200616258024820

GMDN Terms#

Term, Definition table
TermDefinition
Angiographic syringeA sterile, manually-operated device consisting of a barrel (cylinder) with plunger intended to be used for the administration of a contrast medium into the heart, great vessels, and coronary arteries to study the heart and vessels under x-ray photography. It may in addition be intended for introduction of other fluids (e.g., saline). It is not intended to be used with a contrast medium injection system. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity5 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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
049673973
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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

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
0063462495724425ft/7.6m IV Extension Set QUEST MEDICAL INCFPK2020-04-13
10849884002666VYGONVygon CorporationFPK2020-04-02
10849884002765VYGONVygon CorporationFPK2020-04-02
10849884002581VYGONVygon CorporationFPK2020-04-01
00849884004441VYGONVygon CorporationFPK2020-03-12
00849884003956VYGONVygon CorporationFPK2020-01-28
00849884004007VYGONVygon CorporationFPK2020-01-28
10351688507112MedexICU MEDICAL, INC.FPK2020-01-13
00849884000320VYGONVygon CorporationFPK2019-12-16
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
00849884000443VYGONVygon CorporationFPK2019-11-14
00849884000450VYGONVygon CorporationFPK2019-11-14
00849884000467VYGONVygon CorporationFPK2019-11-14
00849884000535VYGONVygon CorporationFPK2019-11-14