Miller Enema Air Tip with Retention Cuff 901202

GUDID 00815112021191

Non latex Air Retention Tip

BRACCO DIAGNOSTICS INC

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• Primary Device ID: 00815112021191
• NIH Device Record Key: 992f58ba-019e-447a-91d3-5225edc053f4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Miller Enema Air Tip with Retention Cuff
• Version Model Number: 901202
• Catalog Number: 901202
• 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
• 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 Dimensions

• Catheter Gauge: 48 French
• Catheter Gauge: 48 French
• Catheter Gauge: 48 French
• Catheter Gauge: 48 French
• Catheter Gauge: 48 French
• Catheter Gauge: 48 French
• Catheter Gauge: 48 French
• Catheter Gauge: 48 French
• Catheter Gauge: 48 French
• Catheter Gauge: 48 French
• Catheter Gauge: 48 French
• Catheter Gauge: 48 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815112021191 [Unit of Use]
GS1	10815112021198 [Primary]
GS1	30815112021192 [Package]; Contains: 10815112021198; 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 [Miller Enema Air Tip with Retention Cuff]

• 30815112020973: Non latex Air Retention Tip
• 00815112021191: Non latex Air Retention Tip