FREESTYLE®
GUDID 00613994348975
VALVE FR995-27 FREESTYLE US NNA
MEDTRONIC, INC.
Aortic heart valve bioprosthesis| Primary Device ID | 00613994348975 |
| NIH Device Record Key | 6aa55dc0-8c19-4605-aef7-ee3fc0eac87f |
| Commercial Distribution Discontinuation | 2017-11-30 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | FREESTYLE® |
| Version Model Number | FR995-27 |
| Company DUNS | 006261481 |
| Company Name | MEDTRONIC, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| 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
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 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 |
Operating and Storage Conditions
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00613994348975 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P970031
FDA Product Code
| LWR | heart-valve, non-allograft tissue |
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 | 2014-09-23 |
On-Brand Devices [FREESTYLE®]
| 00613994348982 | VALVE FR995-29 FREESTYLE US NNA |
| 00613994348975 | VALVE FR995-27 FREESTYLE US NNA |
| 00643169008144 | VLV FR995-29 FREESTYLE AOR US TEMP IND |
| 00643169008137 | VLV FR995-27 FREESTYLE AOR US TEMP IND |
| 00643169002418 | VLV 995MS21 FREESTYLE MS US TEMP IND |
| 00643169002395 | VLV 995MS19 FREESTYLE MS US TEMP IND |
| 00643169002302 | VLV 995CS27 FREESTYLE CS US TEMP IND |
| 00643169002289 | VLV 995CS25 FREESTYLE CS US TEMP IND |
| 00643169002265 | VLV 995CS23 FREESTYLE CS US TEMP IND |
| 00643169002241 | VLV 995CS21 FREESTYLE CS US TEMP IND |
| 00643169002227 | VLV 995CS19 FREESTYLE CS US TEMP IND |
| 00643169002197 | VLV FR995-29 FREESTYLE AOR NNA US TEMP I |
| 00643169002173 | VLV FR995-27 FREESTYLE AOR NNA US TEMP I |
| 00643169002159 | VLV FR995-25 FREESTYLE AOR US TEMP IND |
| 00643169002135 | VLV FR995-23 FREESTYLE AOR US TEMP IND |
| 00643169002111 | VLV FR995-21 FREESTYLE AOR US TEMP IND |
| 00643169002098 | VLV FR995-19 FREESTYLE AOR US TEMP IND |
| 00643169002074 | VLV 995MS29 FREESTYLE MS US TEMP IND |
| 00643169002050 | VLV 995MS27 FREESTYLE MS US TEMP IND |
| 00643169002036 | VLV 995MS25 FREESTYLE MS US TEMP IND |
| 00643169002012 | VLV 995MS23 FREESTYLE MS US TEMP IND |
| 00681490816465 | VALVE FR995-29 FREESTYLE AOR US |
| 00681490265942 | VALVE FR995-27 FREESTYLE AOR US |
| 00681490265904 | VALVE FR995-23 FREESTYLE AOR US |
| 00681490265898 | VALVE FR995-21 FREESTYLE AOR US |
| 00681490219198 | VALVE 995CS27 FREESTYLE CS US |
| 00681490219150 | VALVE 995CS25 FREESTYLE CS US |
| 00681490219112 | VALVE 995CS23 FREESTYLE CS US |
| 00681490219075 | VALVE 995CS21 FREESTYLE CS US |
| 00681490219037 | VALVE 995CS19 FREESTYLE CS US |
| 00721902316197 | VALVE 995MS29 FREESTYLE MS US |
| 00721902316180 | VALVE 995MS27 FREESTYLE MS US |
| 00721902316173 | VALVE 995MS25 FREESTYLE MS US |
| 00721902316166 | VALVE 995MS23 FREESTYLE MS US |
| 00721902316159 | VALVE 995MS21 FREESTYLE MS US |
| 00721902316142 | VALVE 995MS19 FREESTYLE MS US |
| 10681490265918 | VALVE FR99525 FREESTYLE AOR US |
| 10681490265888 | VALVE FR995-19 FREESTYLE AOR US |
Trademark Results [FREESTYLE]
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