Retention Cuff Inflator 900405

GUDID 30815112020881

One Shot Cuff Inflator

BRACCO DIAGNOSTICS INC

Barium enema catheter

• Primary Device ID: 30815112020881
• NIH Device Record Key: 53b0064c-8c28-4b8c-a225-73a3f94754c5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Retention Cuff Inflator
• Version Model Number: 900405
• Catalog Number: 900405
• Company DUNS: 849234661
• Company Name: BRACCO DIAGNOSTICS INC
• Device Count: 12
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 609-514-2200
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815112020880 [Unit of Use]
GS1	10815112020887 [Primary]
GS1	30815112020881 [Package]; Contains: 10815112020887; Package: Box [12 Units]; In Commercial Distribution

FDA Product Code

• FGD: Catheter, Retention, Barium Enema With Bag

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-06-30
• Device Publish Date: 2016-09-19

On-Brand Devices [Retention Cuff Inflator]

• 30815112020881: One Shot Cuff Inflator
• 00815112021221: One Shot Cuff Inflator