Adapta™

GUDID 00613994763259

IPG ADSR01 ADAPTA USA IS-1 SR NEW3 BCP

MEDTRONIC, INC.

Single-chamber implantable pacemaker, rate-responsive

• Primary Device ID: 00613994763259
• NIH Device Record Key: c754730e-c441-4768-ae70-6bb8328cfb4b
• Commercial Distribution Discontinuation: 2018-10-10
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Adapta™
• Version Model Number: ADSR01
• Company DUNS: 006261481
• Company Name: MEDTRONIC, 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: false
• Serial Number: true
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994763259 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P980035

FDA Product Code

• NVN: Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-10-12
• Device Publish Date: 2014-09-23

On-Brand Devices [Adapta™]

• 00613994763259: IPG ADSR01 ADAPTA USA IS-1 SR NEW3 BCP
• 00613994763235: IPG ADDR01 ADAPTA USA IS-1 DR NEW3 BCP
• 00613994222190: IPG, ADSR06, ADAPTA SR 5/6 UNI, CTD, US
• 00613994222176: IPG, ADSR03, ADAPTA, SR, 3.2 MM, US
• 00613994222169: IPG ADSR01P ADAPTA SR IS-1 CTD US
• 00613994222152: IPG, ADSR01, ADAPTA, SR, IS-1, US
• 00613994222107: IPG, ADVDD01, ADAPTA, VDD, IS-1, US
• 00613994222077: IPG, ADDR06, ADAPTA DR, 5/6,UNI, CTD, US
• 00613994222060: IPG, ADDR03, ADAPTA, DR, 3.2 MM, US
• 00613994222046: IPG, ADDR01, ADAPTA, DR, IS-1, US
• 00643169709041: IPG ADSR01 ADAPTA SR IS-1 US NS
• 00643169708860: IPG ADSR06 ADAPTA SR 5/6MM US NS
• 00643169708846: IPG ADSR03 ADAPTA SR 3.2MM US NS
• 00643169708815: IPG ADSR01P ADAPTA SR IS-1 CTD US NS
• 00643169708808: IPG ADSR01 ADAPTA SR IS-1 US NS
• 00643169708778: IPG ADVDD01 ADAPTA VDD IS-1 US NS
• 00643169708662: IPG ADDR06 ADAPTA DR 5/6MM US NS
• 00643169708648: IPG ADDR03 ADAPTA DR 3.2MM US NS
• 00643169708624: IPG ADDR01 ADAPTA DR IS-1 US NS
• 00643169708600: IPG ADDR01 ADAPTA DR IS-1 US NS
• 00763000316792: IPG ADSR06 ADAPTA SR UNI PARYCTD USA
• 00763000316785: IPG ADSR03 ADAPTA SR USA
• 00763000316778: IPG ADSR01P ADAPTA SR PARYCTD USA
• 00763000316761: IPG ADVDD01 ADAPTA VDD USA
• 00763000316730: IPG ADDR06 ADAPTA DR UNI PARYCTD USA
• 00763000316723: IPG ADDR03 ADAPTA DR USA