Entuit C-ENTUIT-16-M-ENF

GUDID 10827002472850

Entuit Gastrostomy Set with ENFit Connection

COOK INCORPORATED

Gastrostomy tube kit, non-medicated Gastrostomy tube kit, non-medicated Gastrostomy tube kit, non-medicated Gastrostomy tube kit, non-medicated Gastrostomy tube kit, non-medicated Gastrostomy tube kit, non-medicated Gastrostomy tube kit, non-medicated Gastrostomy tube kit, non-medicated Gastrostomy tube kit, non-medicated Gastrostomy tube kit, non-medicated Gastrostomy tube kit, non-medicated Gastrostomy tube kit, non-medicated Gastrostomy tube kit, non-medicated Gastrostomy tube kit, non-medicated Gastrostomy tube kit, non-medicated Gastrostomy tube kit, non-medicated Gastrostomy tube kit, non-medicated Gastrostomy tube kit, non-medicated Gastrostomy tube kit, non-medicated Gastrostomy tube kit, non-medicated

• Primary Device ID: 10827002472850
• NIH Device Record Key: 404be157-3e43-4f06-acc2-cbb926acc899
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Entuit
• Version Model Number: G47285
• Catalog Number: C-ENTUIT-16-M-ENF
• Company DUNS: 042823948
• Company Name: COOK INCORPORATED
• 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: 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
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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	10827002472850 [Primary]

FDA Product Code

• PRR: Feeding tube kit

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-08-31
• Device Publish Date: 2020-08-21

On-Brand Devices [Entuit]

• 00827002344440: Entuit Start Initial Placement Gastrostomy Set
• 00827002344433: Entuit Start Initial Placement Gastrostomy Set
• 00827002344426: Entuit Start Initial Placement Gastrostomy Set
• 00827002355705: Entuit Secure Gastrointestinal Suture Anchor Set
• 00827002355699: Entuit Secure Gastrointestinal Suture Anchor Set
• 00827002355637: Entuit Secure Adjustable Gastrointestinal Suture Anchor Set
• 00827002355620: Entuit Secure Adjustable Gastrointestinal Suture Anchor Set
• 10827002472911: Entuit Gastrostomy Set
• 10827002472904: Entuit Gastrostomy Set
• 10827002472898: Entuit Gastrostomy Set
• 10827002472881: Entuit Gastrostomy Set
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• 10827002472867: Entuit Gastrostomy Set with ENFit Connection
• 10827002472850: Entuit Gastrostomy Set with ENFit Connection
• 10827002472843: Entuit Gastrostomy Set with ENFit Connection