Covidien 8884715122E

GUDID 20884521661629

True content to be populated as part of rebranding

Cardinal Health, Inc.

Gastrostomy tube

• Primary Device ID: 20884521661629
• NIH Device Record Key: aba08c11-264b-4095-9906-08c56c2246ab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Covidien
• Version Model Number: 8884715122E
• Catalog Number: 8884715122E
• Company DUNS: 080935429
• Company Name: Cardinal Health, Inc.
• 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: false
• 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(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521661622 [Primary]
GS1	20884521661629 [Package]; Contains: 10884521661622; Package: CASE [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180622

FDA Product Code

• KNT: Tubes, gastrointestinal (and accessories)

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: 2020-06-23
• Device Publish Date: 2020-06-15

On-Brand Devices [Covidien]

• 50885380169494: True content to be populated as part of rebranding
• 50885380167162: Grifols 3038172 TRNSF NDL 20X1.625B
• 50885380167155: Grifols 3037908 FLTR NDL 16X.75I
• 10885380170096: True content to be populated as part of rebranding
• 10885380169779: Kendall DL Disposable Lead Set
• 10884521158795: True content to be populated as part of rebranding
• 10884521162624: HDNDL-E 27X 7/8RBT SMK GRA 11M
• 20884521661629: True content to be populated as part of rebranding
• 10192253002058: Cardinal Health Quilted Premium Strength XXL Underpads Wings
• 10884521768109: True content to be populated as part of rebranding
• 10884521643185: NuPrep Gel
• 10884521643178: Neurodiagnostic Electrode Paste
• 20884521643168: Neurodiagnostic Electrode Paste
• 10884521746886: DL System Direct Connect Philips MX40 Masimo SPO2 5 Lead
• 10884521746862: DL System Direct Connect Philips MX40 Nellcor SPO2 5 Lead
• 10884521517325: KDL System Radiolucent 5 Lead 36" V-lead
• 10884521517257: Kendall DL Disposable Lead Set 5 Lead Radiolucent
• 10884521517233: Kendall DL Disposable Lead Set
• 10884521180390: True content to be populated as part of rebranding
• 10884521174009: True content to be populated as part of rebranding
• 10884521717404: DL System Direct Connect Philips MX40 Non SPO2 5 Lead
• 10884521517349: True content to be populated as part of rebranding
• 10884521517332: TBD during rebranding
• 10884521517264: True content to be populated as part of rebranding
• 10884521517158: True content to be populated as part of rebranding
• 10884521517141: True content to be populated as part of rebranding
• 10884521517134: TBD during rebranding
• 10884521517127: TBD during rebranding
• 20884521189222: True content to be populated as part of rebranding
• 20884521722276: Naso-Jejunal Feeding Tube with ENFit Connection
• 30884521742592: Safety Needle, Thin Wall, 20 Gauge x 1.5 Inch, Bulk, Non-sterile
• 20884521661759: True content to be populated as part of rebranding
• 20884521661742: True content to be populated as part of rebranding
• 20884521661735: True content to be populated as part of rebranding
• 20884521661728: Gastro Feeding Tube with ENfit Y-Port 22FR
• 20884521661711: True content to be populated as part of rebranding
• 20884521661704: True content to be populated as part of rebranding
• 10884521661691: Gastronomy Feed Tube With ENFit Y-Port 16FR
• 20884521661636: Gastro Feed Tube With ENFit Y-Port 14FR