18 French Pediatric Flexi Tip 901308

GUDID 10815112021204

18 Fr Pediatric Flexi Tip

BRACCO DIAGNOSTICS INC

Enema tip, single-use Enema tip, single-use Enema tip, single-use Enema tip, single-use Enema tip, single-use Enema tip, single-use Enema tip, single-use Enema tip, single-use Enema tip, single-use Enema tip, single-use Enema tip, single-use Enema tip, single-use

• Primary Device ID: 10815112021204
• NIH Device Record Key: db3653e2-93f2-4565-8313-24347234955f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 18 French Pediatric Flexi Tip
• Version Model Number: 901308
• Catalog Number: 901308
• 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: 18 French
• Catheter Gauge: 18 French
• Catheter Gauge: 18 French
• Catheter Gauge: 18 French
• Catheter Gauge: 18 French
• Catheter Gauge: 18 French
• Catheter Gauge: 18 French
• Catheter Gauge: 18 French
• Catheter Gauge: 18 French
• Catheter Gauge: 18 French
• Catheter Gauge: 18 French
• Catheter Gauge: 18 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815112021207 [Unit of Use]
GS1	10815112021204 [Primary]
GS1	30815112021208 [Package]; Package: [24 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 [18 French Pediatric Flexi Tip]

• 30815112021062: 18 Fr Pediatric Flexi Tip
• 10815112021204: 18 Fr Pediatric Flexi Tip