Primary Device ID | 20763000725543 |
NIH Device Record Key | 4b1a601e-f28a-43fd-afb6-92c06d1e002d |
Commercial Distribution Status | In Commercial Distribution |
Version Model Number | 6208-S5 |
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 | 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 |
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 |
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 |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00763000725549 [Primary] |
GS1 | 20763000725543 [Package] Contains: 00763000725549 Package: PK [5 Units] In Commercial Distribution |
DYB | Introducer, catheter |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-11-26 |
Device Publish Date | 2024-11-18 |
00199150031610 - NA | 2025-07-21 CUSTOM PACK BB1U06R24 CHRIS AD |
00199150032464 - NA | 2025-07-21 CUSTOM PACK BB10R35R4 CP PRIME |
20199150032482 - NA | 2025-07-21 CUSTOM PACK 6S19R4 10PK DIALYSIS |
00199150033423 - NA | 2025-07-21 CUSTOM PACK BB12B90R7 SPECTRU |
20199150033571 - NA | 2025-07-21 CUSTOM PACK BB2U59R3 2PK 1/4 TBL L |
00199150033614 - NA | 2025-07-21 CUSTOM PACK BB10J74R14 3/8CNTRIS |
00199150034246 - NA | 2025-07-21 CUSTOM PACK BB11J86R12 ADULT E |
00763000925093 - FlexCath Cross™ Transseptal Solution | 2025-07-21 NDL 900302 FLEXCATH CROSS SL 63CM EIFU |