Enema Kit: Empty Enema Bag Delivery System 900302

GUDID 30815112020812

Empty Snap Cap Bag

BRACCO DIAGNOSTICS INC

Enema tube

• Primary Device ID: 30815112020812
• NIH Device Record Key: a82eafc1-db33-4ea8-afd2-b70b715b9b94
• 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: false
• 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	10815112020818 [Primary]
GS1	30815112020812 [Package]; Contains: 10815112020818; 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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-06-30
• Device Publish Date: 2016-09-19

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