CooperSurgical, Inc.

GUDID 30888937003247

Adult Esophageal Balloon Catheter Set; PTFE Coated Stylet; 5 French

Coopersurgical, Inc.

Oesophageal balloon catheter Oesophageal balloon catheter Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use

• Primary Device ID: 30888937003247
• NIH Device Record Key: 65075d98-7480-4c50-b467-3a09b152d119
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CooperSurgical, Inc.
• Version Model Number: 47-9005
• Company DUNS: 801895244
• Company Name: Coopersurgical, 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	20888937003240 [Package]; Contains: 60888937003248; Package: [5 Units]; In Commercial Distribution
GS1	30888937003247 [Package]; Contains: 60888937003248; Package: [20 Units]; In Commercial Distribution
GS1	60888937003248 [Primary]

FDA Product Code

• GBA: Catheter, Balloon Type

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-15

On-Brand Devices [CooperSurgical, Inc.]

• 30888937003247: Adult Esophageal Balloon Catheter Set; PTFE Coated Stylet; 5 French
• 00888937011135: Cervical Sizer
• 00888937010015: 16 Gauge Tip, 1 1/2" Needle, Curved
• 00888937010008: 16 Gauge Tip, 1 1/2" Needle
• 00888937009996: 14 Gauge Tip, 3" Needle, Curved, Long
• 00888937009989: 14 Gauge Tip, 3" Needle
• 20888937003691: 1X Macro Bipolar Insert (Long)
• 20888937003684: 1X Macro Bipolar Insert