FDA.reportPublic FDA data

Waste Bottle

Primary DI
10815112020054
Brand
Waste Bottle
Company
Bracco Diagnostics Inc.
Model
001520
Device description
Waste Bottle for use with CardioGen-82 Infusion System
Published
2023-03-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IWWShield, Vial

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IWWShield, VialRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30815112020058PackageGS12In Commercial Distribution
10815112020054PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3081511202005830815112020058
1081511202005410815112020054

GMDN Terms#

Term, Definition table
TermDefinition
General laboratory container, single-useA container (e.g., test tube, bottle, cup, assay tray with large wells) intended to be used as a non-dedicated receptacle to hold consumable laboratory substances (e.g., reagents, buffers), specimens, and other materials associated with procedures in the laboratory; it is not intended for in vitro diagnostic procedures. It is typically made of plastic or glass and may be used on the benchtop for manual procedures, or on-board automated liquid handling instruments or analysers. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
800-447-6883xx@xx.xx

Regulatory Flags#

DUNS number
849234661
Device count
1
Combination product
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10815112020214Fast Find Grid: Disposable CT Biopsy Grid6000016000012016-09-19
10815112021167Rounded Flexi Tip Adult Enema Tip9013019013012023-05-25
10815112021181Miller Enema Air Tip with Non-Latex Retention Cuff9012019012012023-05-25
10815112021198Miller Enema Air Tip with Retention Cuff9012029012022023-05-25
30815112021703Two Tank Shuttle Valve System7106027106022025-06-30
30815112021710DIN 477 High Pressure Hose for CO23905133905132025-06-30
30815112021291High Pressure Hose and Yoke7106037106032023-08-31
10815112021174Enema Kit: Empty Enema Bag Delivery System9003029003022023-05-25
1081511202120418 French Pediatric Flexi Tip9013089013082023-05-25
30815112020805High Pressure DISS Hose For CO27106047106042016-09-19
30815112020782Two Tank Shuttle Valve System7106027106022016-09-19
10815112020535E-Z-GEL UltraSound Gel6010016010012016-09-23
10815112020542E-Z-SCAN Low Viscosity UltraSound Gel6010026010022016-09-23
10815112020559E-Z-SCAN Low Viscosity UltraSound Gel6010036010032016-09-23
10815112020566E-Z-GEL UltraSound Gel6010046010042016-09-23
10815112021402E-Z-GEL UltraSound Gel6010016010012025-05-16
10815112021419E-Z-SCAN Low Viscosity UltraSound Gel6010026010022025-05-16
10815112021426E-Z-SCAN Low Viscosity UltraSound Gel6010036010032025-05-16
10815112021433E-Z-GEL UltraSound Gel6010046010042025-05-16
10815112020856"""Y"" Connector with Tubing"9004029004022016-09-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10815112021365Vented Cap for Waste Bottle Bracco Diagnostics Inc.IWW2023-10-16
10815112021372Waste BottleBracco Diagnostics Inc.IWW2023-10-16
30815112021369Vented Cap for Waste Bottle BRACCO DIAGNOSTICS INCIWW2023-10-16
30815112021376Waste BottleBRACCO DIAGNOSTICS INCIWW2023-10-16
30815112021383Elution Test Vial ShieldBracco Diagnostics Inc.IWW2023-06-23
10815112020047Vented Cap for Waste Bottle Bracco Diagnostics Inc.IWW2023-03-22
30815112020041Vented Cap for Waste Bottle BRACCO DIAGNOSTICS INCIWW2023-03-22
30815112020058Waste BottleBRACCO DIAGNOSTICS INCIWW2023-03-22
30815112020072Elution Test Vial Bracco Diagnostics Inc.IWW2023-03-22
10815112020085Elution Test Vial ShieldBracco Diagnostics Inc.IWW2023-03-21
00879942070002High Density Lead Glass Vial ShieldMirion Technologies (capintec), Inc.IWW2022-07-11
00879942070019PET Vial PigMirion Technologies (capintec), Inc.IWW2022-07-11
00879942070026Vial Shield, LeadMirion Technologies (capintec), Inc.IWW2022-07-11
00879942070033Dose Drawing Vial Shield, PET 30 mlMirion Technologies (capintec), Inc.IWW2022-07-11
00879942070040Dose Drawing Vial Shield, PET 50 mlMirion Technologies (capintec), Inc.IWW2022-07-11
00879942070064Vial Shield, Lead with Magnetic CapMirion Technologies (capintec), Inc.IWW2022-07-11
00879942070071Vial Shield, Lead with Magnetic Cap and Glass WindowMirion Technologies (capintec), Inc.IWW2022-07-11
00879942070088Tungsten Vial Shield with Magnetic CapMirion Technologies (capintec), Inc.IWW2022-07-11
00879942070095Tungsten Vial ShieldMirion Technologies (capintec), Inc.IWW2022-07-11
00850014612078SIR-Spheres V-Vial HolderSirtex Medical Inc.IWW2021-07-14
00850014612016SIROS D-Vial Prep SetSirtex Medical Inc.IWW2021-01-05
00718175008478VIAL SHIELDBIODEX MEDICAL SYSTEMS, INC.IWW2020-04-13
00718175008614VIAL SHIELDBIODEX MEDICAL SYSTEMS, INC.IWW2020-04-13
00718175008850VIAL SHIELDBIODEX MEDICAL SYSTEMS, INC.IWW2020-04-13
00718175009086VIAL SHIELDBIODEX MEDICAL SYSTEMS, INC.IWW2020-04-13
00859942006317Capintec 511 T-Vial ShieldMirion Technologies (capintec), Inc.IWW2019-07-01
00718175000809VIAL SHIELDBIODEX MEDICAL SYSTEMS, INC.IWW2019-04-12
00718175000755HIGH DENSITY LEAD GLASS VIAL SHIELDBIODEX MEDICAL SYSTEMS, INC.IWW2019-04-10
00718175001707PET VIAL PIGBIODEX MEDICAL SYSTEMS, INC.IWW2018-12-15
00718175001714INTEGOBIODEX MEDICAL SYSTEMS, INC.IWW2018-12-15