Paparella

GUDID 20681490029579

VENT TUBE 1026045 ACTIVENT 5PK PAPA 2

MEDTRONIC XOMED, INC.

Tympanostomy tube

• Primary Device ID: 20681490029579
• NIH Device Record Key: ca7e873f-56ff-43e6-becd-9c5b1d05516f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Paparella
• Version Model Number: 1026045
• Company DUNS: 835465063
• Company Name: MEDTRONIC XOMED, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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: false
• 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(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00681490029575 [Primary]
GS1	20681490029579 [Package]; Contains: 00681490029575; Package: PK [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K941407

FDA Product Code

• ETD: TUBE, TYMPANOSTOMY

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: 2018-07-06
• Device Publish Date: 2015-06-15

On-Brand Devices [Paparella]

• 20613994146124: VENT TUBE 1082203 50PK PAPA TYPE 1.14
• 20613994146117: VENT TUBE 1082202 10PK PAPA TYPE PR 1.14
• 20613994146100: VENT TUBE 1082201 5PK PAPA TYPE 1.14
• 20681490825478: VENT TUBE MV1027 10PK PAPARELLA 1.14MM
• 20681490306816: VENT TUBE MV1076 10PK PAPA TYPE 2 1.52MM
• 20681490063306: VENT TUBE 25442 10PK PAPA PAIR .040 SIL
• 20681490063290: VENT TUBE 25441 MICROGEL 5PK PAPA 1.02
• 20681490062712: VENT TUBE 24461 5PK PAPA FIRM SIL 1.27MM
• 20681490062705: VENT TUBE 24452 10PK PAPA PAIR 1.02 SIL
• 20681490062699: VENT TUBE 24451 5PK PAPA FIRM SIL 1.02MM
• 20681490062682: VENT TUBE 24442 10PK PAPA PAIR 1.02 SIL
• 20681490062675: VENT TUBE 24441 5PK PAPA FIRM SIL 1.02MM
• 20681490041151: VENT TUBE 14521 5PK PAPA W/TAB 1.02 FLPL
• 20681490032432: VENT TUBE 1066005 10PK PAPA PAIRS 1.02MM
• 20681490031770: VENT TUBE 1056005 5PK PAPA W/TAB 1.02
• 20681490031350: VENT TUBE 1046001 10PK PAPA 1 PAIRS
• 20681490031138: VENT TUBE 1040019 100PK PAPA PAIR 1.14
• 20681490031077: VENT TUBE 1040006 10PK PAPA PR 1.14 SIL
• 20681490029579: VENT TUBE 1026045 ACTIVENT 5PK PAPA 2
• 20681490029487: VENT TUBE 1026001 ACTIVENT 5PK PAPA 1
• 20681490029401: VENT TUBE 1025045 5PK PAPA NTCH/TAB 1.52
• 20681490029395: VENT TUBE 1025040 5PK PAPA W/NOTCH 1.52
• 20681490029357: VENT TUBE 1025005 5PK PAPA W/NOTCH 1.14
• 20681490029326: VENT TUBE 1025002 50PK PAPA NOTCH/TAB
• 20681490029319: VENT TUBE 1025001 5PK PAPA NOTCH/TAB SIL
• 20681490028299: VENT TUBE 1012010 5PK PAPARELLA W/MEMBR
• 20763000039961: VENT TUBE 14521 5PK PAPA W/TAB 1.02 FLPL
• 20763000040387: VENT TUBE 24452 10PK PAPA PAIR 1.02 SIL
• 20763000040370: VENT TUBE 24451 5PK PAPA FIRM SIL 1.02MM
• 20763000040363: VENT TUBE 24442 10PK PAPA PAIR 1.02 SIL
• 20763000040356: VENT TUBE 24441 5PK PAPA FIRM SIL 1.02MM
• 20763000039213: VENT TUBE 1040019 100PK PAPA PAIR 1.14
• 20763000039190: VENT TUBE 1040006 10PK PAPA PR 1.14 SIL
• 20763000038759: VENT TUBE 1025045 5PK PAPA NTCH/TAB 1.52
• 20763000038728: VENT TUBE 1025005 5PK PAPA W/NOTCH 1.14
• 20763000038704: VENT TUBE 1025002 50PK PAPA NOTCH/TAB
• 20763000038698: VENT TUBE 1025001 5PK PAPA NOTCH/TAB SIL
• 20763000041049: VENT TUBE MV1027 10PK PAPARELLA 1.14MM
• 20763000040929: VENT TUBE MV1076 10PK PAPA TYPE 2 1.52MM