FDA.reportPublic FDA data

MEDRAD® XDS Patient Interface Disposable

Primary DI
40616258010210
Brand
MEDRAD® XDS Patient Interface Disposable
Company
BAYER MEDICAL CARE INC.
Model
XDS PID
Catalog number
XDS PID
Device description
XDS Patient Interface Disposable (Assembly, PID, Extravasation,MC,JA2) (85258346)
Published
2019-05-20
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
KGXTape And Bandage, Adhesive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGXTape And Bandage, AdhesiveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40616258010210PackageGS1100In Commercial Distribution
00616258010212PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
4061625801021040616258010210
00616258010212006162580102126162580102120616258010212

GMDN Terms#

Term, Definition table
TermDefinition
Adhesive bandageA sterile piece of fabric or plastic material intended to be applied to a part of a patient's body and held in place by its pressure-sensitive adhesive to secure objects to the skin, cover and protect wounds, and/or approximate the skin edges of a wound; it may or may not include an absorbent pad. It is not intended for compression bandaging and is not an adhesive tape nor an adhesive strip (e.g., such as an Elastoplast or Band-aid brand). This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
058716649
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
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
00616258024042MEDRAD® Avanta Single Patient Disposable Set - AngioAVA 500 SPAT ANGIOAVA 500 SPAT ANGIO2024-07-08
40616258024002MEDRAD® Avanta Multi-Patient Disposable SetAVA 500 MPAT (Part 2 of 2)AVA 500 MPAT (Part 2 of 2)2024-07-04
40616258024088MEDRAD® Avanta Single Patient Disposable Set – Transducer CompatibleAVA 500 SPAT LAVA 500 SPAT L2024-07-03
00616258027340Imaging System Interface - ISI2 ModuleISI2ISI22024-06-17
00616258022512Imaging System Interface - ISI2 ModuleISI2ISI22024-05-06
00616258023793MEDRAD® Mark 7 Arterion Injection SystemART 700ART 7002024-05-06
40616258024309Disposable MRI Kit with Check ValveSQK 65VSSQK 65VS2024-05-06
40616258024316Disposable MRI Kit for 65/115 MR Injector SystemSSQK 65/115VSSSQK 65/115VS2024-05-06
40616258024323MEDRAD® MRXperion Sterile Disposable MRI KitXP 65/115VSXP 65/115VS2024-05-06
40616258024330MEDRAD® Mark V ProVis Sterile Disposable Syringe 150mL & QFT150-FT-Q150-FT-Q2024-05-06
40616258024347MEDRAD® Mark V ProVis 200mL FasTurn Sterile Disposable Syringe & QFT200-FT-Q200-FT-Q2024-05-06
40616258024354MEDRAD® Mark 7 Arterion Disposable Syringe 150 mL with Quick Fill TubeART 700 SYRART 700 SYR2024-05-06
40616258024361MEDRAD® Avanta Multi-Patient Disposable SetAVA 500 MPAT (Part 1 of 2)AVA 500 MPAT (Part 1 of 2)2024-05-06
40616258024385CT TRI-PAK Sterile Disposable SyringeCTP-200-FLSCTP-200-FLS2024-05-06
40616258024415MEDRAD® Intego Patient Administration SetINT CPSINT CPS2024-05-06

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