Primary Device ID | 00763000442842 |
NIH Device Record Key | 0b9ae022-1dcd-40d5-9cdb-00c44bc1a771 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | DiamondTemp™ Generator Connection Box E |
Version Model Number | CEDTGCB100 |
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 | false |
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 |
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 |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00763000442842 [Primary] |
OAE | Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2021-10-11 |
Device Publish Date | 2021-10-02 |
00763000944322 - NA | 2024-04-23 CUSTOM PACK HY4953R31 MEMB PK |
00763000944339 - NA | 2024-04-23 CUSTOM PACK BB12F73R1 AHO PACK |
00763000944346 - NA | 2024-04-23 CUSTOM PACK BB12F35R5 A PACK |
00763000945558 - NA | 2024-04-23 CUSTOM PACK CB11X44R5 3/16X1/4 NEO |
00763000943844 - NA | 2024-04-12 CUSTOM PACK BB11J59R5 PEDS |
00763000943851 - NA | 2024-04-12 CUSTOM PACK BB12F35R3 A PACK |
00763000943868 - NA | 2024-04-12 CUSTOM PACK CB9J12R4 PED SPRT |
00763000943899 - NA | 2024-04-12 CUSTOM PACK BB12E09R3 INVO DCD |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
DIAMONDTEMP 87036983 5950458 Live/Registered |
EPIX THERAPEUTICS, INC. 2016-05-13 |