FDA.reportPublic FDA data

Waste Bottle

Primary DI
30815112021376
Brand
Waste Bottle
Company
BRACCO DIAGNOSTICS INC
Model
001520
Device description
Waste Bottle for use with CardioGen-82 Infusion System
Published
2023-10-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

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
30815112021376PackageGS12In Commercial Distribution
10815112021372PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3081511202137630815112021376
1081511202137210815112021372

GMDN Terms#

Term, Definition table
TermDefinition
General laboratory container, single-useA container (e.g., test tube, bottle, cup) 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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
849234661
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
true
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
30815112021390CardioGen-82 Infusion System Model 17000017002023-12-01
30815112021352CardioGen Patient Administration Set0015062023-10-16
30815112021369Vented Cap for Waste Bottle 0015112023-10-16
30815112021239Protocol Touch Colon Insufflator3903083903082023-08-31
30815112021086Enteroclysis Admin Kit9014039014032016-09-19
30815112021260Protocol Accessory Cart3903053903052023-07-07
30815112021246Protocol Touch Administration Set with Small Catheter and Retention Cuff3903093903092023-06-29
30815112021284Protocol Administration Set with Small Catheter and Retention Cuff3904023904022023-06-29
50815112021332Accessory Package0017102023-06-29
30815112021161Rounded Flexi Tip Adult Enema Tip9013019013012023-05-25
00815112021184Miller Enema Air Tip with Non-Latex Retention Cuff9012019012012023-05-25
00815112021191Miller Enema Air Tip with Retention Cuff9012029012022023-05-25
00815112021214Blue Air Bulb Insufflator9004049004042023-05-25
00815112021221Retention Cuff Inflator9004059004052023-05-25
30815112020041Vented Cap for Waste Bottle 0015112023-03-22
30815112020058Waste Bottle0015202023-03-22
50815112020038Accessory Package0015102023-03-22
50815112020618Accessory Package0017102023-03-22
30815112020539E-Z-GEL UltraSound Gel6010016010012016-09-23
30815112020546E-Z-SCAN Low Viscosity UltraSound Gel6010026010022016-09-23

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
30815112021383Elution Test Vial ShieldBracco Diagnostics Inc.IWW2023-06-23
10815112020047Vented Cap for Waste Bottle Bracco Diagnostics Inc.IWW2023-03-22
10815112020054Waste BottleBracco 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