Primary Device ID | 00763000181321 |
NIH Device Record Key | 3be5893e-94c6-4ea9-9097-4b7b496f551a |
Commercial Distribution Status | In Commercial Distribution |
Version Model Number | 2090EC |
Company DUNS | 006261481 |
Company Name | MEDTRONIC, INC. |
Device Count | 1 |
DM Exempt | true |
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 | false |
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 |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com | |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com | |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com | |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com | |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com | |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com | |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com | |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com | |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com | |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com | |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com | |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com | |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com | |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com | |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com | |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com |
Length | 1.83 Meter |
Length | 1.83 Meter |
Length | 1.83 Meter |
Length | 1.83 Meter |
Length | 1.83 Meter |
Length | 1.83 Meter |
Length | 1.83 Meter |
Length | 1.83 Meter |
Length | 1.83 Meter |
Length | 1.83 Meter |
Length | 1.83 Meter |
Length | 1.83 Meter |
Length | 1.83 Meter |
Length | 1.83 Meter |
Length | 1.83 Meter |
Length | 1.83 Meter |
Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00763000181321 [Primary] |
OSR | Pacemaker/icd/crt non-implanted components |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00763000181321]
Ethylene Oxide
[00763000181321]
Ethylene Oxide
[00763000181321]
Ethylene Oxide
[00763000181321]
Ethylene Oxide
[00763000181321]
Ethylene Oxide
[00763000181321]
Ethylene Oxide
[00763000181321]
Ethylene Oxide
[00763000181321]
Ethylene Oxide
[00763000181321]
Ethylene Oxide
[00763000181321]
Ethylene Oxide
[00763000181321]
Ethylene Oxide
[00763000181321]
Ethylene Oxide
[00763000181321]
Ethylene Oxide
[00763000181321]
Ethylene Oxide
[00763000181321]
Ethylene Oxide
[00763000181321]
Ethylene Oxide
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2021-06-21 |
Device Publish Date | 2021-06-12 |
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00763000998271 - Affera™ Integrated Mapping System | 2025-09-01 MAP SYS AFR-00016 IMPEDANCE US PLX |
00199150042005 - NA | 2025-08-29 CUSTOM PACK BB7E29R28 EVL 3/8 |
00199150042012 - NA | 2025-08-29 CUSTOM PACK BB11L88R8 EVL SUPPRT SM |
00199150042029 - NA | 2025-08-29 CUSTOM PACK BB12P62R3 EVL 1/4 |