Enema Kit: Empty Enema Bag Delivery System 900302

GUDID 10815112021174

Empty Snap Cap Bag

BRACCO DIAGNOSTICS INC

Enema tube Enema tube Enema tube Enema tube Enema tube Enema tube Enema tube Enema tube Enema tube Enema tube Enema tube Enema tube

• Primary Device ID: 10815112021174
• NIH Device Record Key: 98136ce3-2f0d-4e44-b8c2-76d15d26e460
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Enema Kit: Empty Enema Bag Delivery System
• Version Model Number: 900302
• Catalog Number: 900302
• Company DUNS: 849234661
• Company Name: BRACCO DIAGNOSTICS INC
• Device Count: 1
• 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
• Phone: 609-514-2200
• Email: xx@xx.xx
• Phone: 609-514-2200
• Email: xx@xx.xx
• Phone: 609-514-2200
• Email: xx@xx.xx
• Phone: 609-514-2200
• Email: xx@xx.xx
• Phone: 609-514-2200
• Email: xx@xx.xx
• Phone: 609-514-2200
• Email: xx@xx.xx
• Phone: 609-514-2200
• Email: xx@xx.xx
• Phone: 609-514-2200
• Email: xx@xx.xx
• Phone: 609-514-2200
• Email: xx@xx.xx
• Phone: 609-514-2200
• Email: xx@xx.xx
• Phone: 609-514-2200
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10815112021174 [Primary]
GS1	30815112021178 [Package]; Package: Box [48 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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-02
• Device Publish Date: 2023-05-25

On-Brand Devices [Enema Kit: Empty Enema Bag Delivery System]

• 30815112020829: Empty Snap Cap Bag
• 30815112020812: Empty Snap Cap Bag
• 10815112020634: Empty Snap Cap Bag
• 10815112021174: Empty Snap Cap Bag