Guardia K-JETS-7019-INT

GUDID 00827002023468

Guardia Access Embryo Transfer Catheter With Internal Support Cannula

COOK INCORPORATED

Assisted reproduction transfer catheter/set

• Primary Device ID: 00827002023468
• NIH Device Record Key: c7d785bf-276a-43d7-b8a9-0c82c12d3841
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Guardia
• Version Model Number: G02346
• Catalog Number: K-JETS-7019-INT
• Company DUNS: 042823948
• Company Name: COOK INCORPORATED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00827002023468 [Primary]

FDA Product Code

• MQF: CATHETER, ASSISTED REPRODUCTION

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-01-23
• Device Publish Date: 2016-09-24

On-Brand Devices [Guardia]

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• 00827002538696: Guardia ProET Protective Embryo Transfer Catheter With Echotip,
• 00827002532472: Guardia AccessET Embryo Transfer Catheter
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• 00827002491342: Guardia Pro Protective Embryo Transfer Catheter
• 00827002347847: Guardia Access Malleable Obturator
• 00827002347830: Guardia Access Embryo Transfer Catheter
• 00827002347823: Guardia Access Embryo Transfer Catheter
• 10827002242170: Guardia Obturator Stiff Adjustable Obturator
• 00827002242166: Guardia Access Nano Embryo Transfer Catheter
• 00827002242159: Guardia Access Nano Embryo Transfer Catheter