Covidien 8884715122E

GUDID 20884521661629

True content to be populated as part of rebranding

Cardinal Health, Inc.

Gastrostomy tube Gastrostomy tube Gastrostomy tube Gastrostomy tube Gastrostomy tube Gastrostomy tube Gastrostomy tube Gastrostomy tube Gastrostomy tube Gastrostomy tube Gastrostomy tube Gastrostomy tube Gastrostomy tube Gastrostomy tube Gastrostomy tube Gastrostomy tube Gastrostomy tube Gastrostomy tube Gastrostomy tube Gastrostomy tube Gastrostomy tube Gastrostomy tube Gastrostomy tube Gastrostomy tube Gastrostomy tube Gastrostomy tube Gastrostomy tube Gastrostomy tube Gastrostomy tube Gastrostomy tube Gastrostomy tube Gastrostomy tube Gastrostomy tube Gastrostomy tube Gastrostomy tube Gastrostomy tube Gastrostomy tube Gastrostomy tube Gastrostomy tube Gastrostomy tube Gastrostomy tube Gastrostomy tube Gastrostomy tube Gastrostomy tube Gastrostomy tube Gastrostomy tube Gastrostomy tube 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