FDA.reportPublic FDA data

MEDRAD® Intego Sterile Disposables

Primary DI
00616258005294
Brand
MEDRAD® Intego Sterile Disposables
Company
BAYER MEDICAL CARE INC.
Model
INT CSS
Catalog number
INT CSS
Device description
Intego Source Admin Set (SAS)(Intego - Source Administration Set)(60766884)
Published
2016-09-24
Public version status
Update
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
FRNPump, Infusion

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRNPump, InfusionGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K080297000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K080297000MEDRAD INTEGO PET INFUSION SYSTEMMedrad, Inc.2008-06-17FRN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10616258005291PackageGS120In Commercial Distribution
00616258005294PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1061625800529110616258005291
00616258005294006162580052946162580052940616258005294

GMDN Terms#

Term, Definition table
TermDefinition
Electric infusion pump administration set, single-useA collection of sterile devices (e.g., plastic tubing, check valve, roller clamp, Y-site connector, Luer, needle/catheter) intended to be used in combination with an electrically-powered infusion pump for the intravenous (IV), subcutaneous, intramuscular, or epidural administration of medication. This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
058716649
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08500835120017Avoset Optum Homecare InfusionOptum Distribution Center, LLCFRN2026-02-24
17290109155309Sapphire M.T. Pump Kit CEITAN MEDICAL LTDFRN2024-09-04
30815112021345Elution Test Vial Bracco Diagnostics Inc.FRN2024-02-13
10815112021396CardioGen-82 Infusion System Model 1700Bracco Diagnostics Inc.FRN2023-12-01
10815112021358CardioGen Patient Administration SetBracco Diagnostics Inc.FRN2023-10-16
17290109155149Sapphire Epidural Infusion Kit - US EITAN MEDICAL LTDFRN2023-09-05
30815112021338Accessory PackageBracco Diagnostics Inc.FRN2023-06-29
30815112020034Accessory PackageBracco Diagnostics Inc.FRN2023-03-22
30815112020614Accessory PackageBracco Diagnostics Inc.FRN2023-03-22
17290109154272Sapphire Epidural Infusion Pump Kit – USEITAN MEDICAL LTDFRN2022-05-15
17290109154289Sapphire M.T Infusion Pump Kit- US - S kit EITAN MEDICAL LTDFRN2022-05-15
17290109154265Sapphire M.T Infusion Pump Kit – USEITAN MEDICAL LTDFRN2022-05-11
10814844000365Curlin IV Pump SystemZEVEX INTERNATIONAL, INC.FRN2021-04-29
15019517177367PharmGuardICU MEDICAL, INC.FRN2020-03-20
15019517177374PharmGuardICU MEDICAL, INC.FRN2020-03-20
10884521064843KangarooCardinal Health, Inc.FRN2019-12-30
15019517155143MEDFUSIONICU MEDICAL, INC.FRN2019-09-20
15019517155150MEDFUSIONICU MEDICAL, INC.FRN2019-09-20
15019517155167MEDFUSIONICU MEDICAL, INC.FRN2019-09-20
15019517178067MedfusionICU MEDICAL, INC.FRN2019-09-18
20763000273334MiniMed™ ReservoirMEDTRONIC MINIMED, INC.FRN2019-09-02
20763000273358MiniMed™ ReservoirMEDTRONIC MINIMED, INC.FRN2019-09-02
M33513852011Plum 360ICU MEDICAL, INC.FRN2019-02-15
70643169771481MiniMed™ ReservoirMEDTRONIC MINIMED, INC.FRN2018-05-31
08050616611635APO-GO Syringe reservoirCANE' SPAFRN2018-05-28
17290109150229SapphirePlus Infusion Kit - USEITAN MEDICAL LTDFRN2018-02-22
09350902001614Flow Control TubingGO MEDICAL INDUSTRIES PTY. LTD.FRN2017-05-18
09350902001690Flow Control TubingGO MEDICAL INDUSTRIES PTY. LTD.FRN2017-05-18
09350902001720Flow Control TubingGO MEDICAL INDUSTRIES PTY. LTD.FRN2017-05-18
09350902001751Flow Control TubingGO MEDICAL INDUSTRIES PTY. LTD.FRN2017-05-18