Primary Device ID | 20763000482163 |
NIH Device Record Key | f2d334a6-b5ab-49c6-86f1-8fefcd71c40b |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | DiamondTemp™ Irrigation Tubing Set |
Version Model Number | CEDTTS100 |
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 | 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 |
Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00763000482169 [Primary] |
GS1 | 20763000482163 [Package] Contains: 00763000482169 Package: PK [5 Units] In Commercial Distribution |
OAE | Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2021-10-29 |
Device Publish Date | 2021-10-21 |
20763000482163 | TUBING SET CEDTTS100 5PK US |
20763000687988 | TUBING SET CEDTTS100 5PK US/CAN |
00763000709174 | TUBING SET CEDTTS100 5PK US |
00763000709181 | TUBING SET CEDTTS100 5PK US |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
DIAMONDTEMP 87036983 5950458 Live/Registered |
EPIX THERAPEUTICS, INC. 2016-05-13 |