| Primary Device ID | 00643169489400 |
| NIH Device Record Key | 523f5470-e855-483e-a59a-0b1ce45786f2 |
| Commercial Distribution Discontinuation | 2018-10-24 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Custom Perfusion System |
| Version Model Number | TL7U29R5 |
| 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 | true |
| Device Combination Product | true |
| 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 |
| 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 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00643169489400 [Primary] |
| KFM | PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-01-04 |
| Device Publish Date | 2014-09-23 |
| 00613994952318 | CUSTOM PACK TL4F97R16 BAPTIST |
| 00613994950079 | CUSTOM PACK CB5Q90R4 JP PACK |
| 00613994947918 | CUSTOM PACK CB5G00R18 PEDI E |
| 00613994946669 | CUSTOM PACK CB1Q18R11 LNG TERM |
| 00613994934987 | CUSTOM PACK HY2W90R17 P - T |
| 00613994934864 | CUSTOM PACK HY6W90R1 CORR PACK |
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| 00613994930392 | CUSTOM PACK CB6L76R1 SUPPORT |
| 00613994929570 | CUSTOM PACK CB6T52R2 ADLT SUPP |
| 00613994923370 | CUSTOM PACK TL6X80R MASONIC 2 |
| 00613994921734 | CUSTOM PACK HY6M21R1 ADLT RES |
| 00613994917744 | CUSTOM PACK TL6V46R4 ADULT CP |
| 00613994917669 | CUSTOM PACK HY6B01R13 HEART |
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| 00613994909084 | CUSTOM PACK CB5175R13 PEDIATRI |
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| 00613994907530 | CUSTOM PACK CB6X08R MGHLH |
| 00613994877246 | CUSTOM PACK CB6U76R1 VA ADULT |
| 00613994872456 | CUSTOM PACK 6T01R2 ADULT E |
| 00613994871367 | CUSTOM PACK CB4S43R9 AFFINITY |
| 00613994859976 | CUSTOM PACK HY1C73R22 ARNOTS |
| 00613994853011 | CUSTOM PACK TL5V20R4 LA CVT |
| 00613994852045 | CUSTOM PACK TL6U52R BIO PUMP |
| 00613994837790 | CUSTOM PACK CB6S67R L H BYPASS |
| 00613994808974 | CUSTOM PACK TL6T18R1 SHUNT PK |
| 00613994806444 | CUSTOM PACK TL6S28R2 FEMFEM SP |
| 00613994803948 | CUSTOM PACK CB6Q04R SUPPORT |
| 00613994803191 | CUSTOM PACK CB5B43R5 3/8 PUMP |
| 00613994798923 | CUSTOM PACK HY2Q32R3 P/T PGIA |
| 00613994795038 | CUSTOM PACK HY2Q31R3 P/T CPGIA |
| 00613994778710 | CUSTOM PACK HY5333R16 1/4 CPS |
| 00613994776556 | CUSTOM PACK TL5N94R2 MASONICAD |
| 00613994774132 | CUSTOM PACK CB6Q97R2 V SUPPRT |
| 00613994773623 | CUSTOM PACK CB4W67R10 ADULT E |
| 00613994773098 | CUSTOM PACK CB4M26R2 L SUPPORT |
| 00613994772879 | CUSTOM PACK HY1W12R19 CV |
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| 00613994756978 | CUSTOM PACK HY6Q18R1 OPEN SYS |
| 00613994756084 | CUSTOM PACK TL5Z15R6 E SUPPORT |
| 00613994753489 | CUSTOM PACK HY3L72R3 L PACK |
| 00613994753472 | CUSTOM PACK CB4907R13 L/T SPRT |
| 00613994752376 | CUSTOM PACK HY5D70R3 VACUUM PK |
| 00613994751386 | CUSTOM PACK 6Q49R1 UNCOATED |
| 00613994748065 | CUSTOM PACK CB1Q95R6 ADLT V |