| Primary Device ID | 30389701007923 |
| NIH Device Record Key | 3cb2c0b0-1227-4532-b940-0f276b686def |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GLIDEACCESS |
| Version Model Number | RSM05 |
| Catalog Number | RSM05 |
| Company DUNS | 131489882 |
| Company Name | TERUMO MEDICAL CORPORATION |
| 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 | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Catheter Gauge | 4 French |
| Catheter Gauge | 4 French |
| Catheter Gauge | 4 French |
| Device Size Text, specify | 0 |
| Length | 10 Centimeter |
| Catheter Gauge | 4 French |
| Device Size Text, specify | 0 |
| Length | 10 Centimeter |
| Catheter Gauge | 4 French |
| Device Size Text, specify | 0 |
| Length | 10 Centimeter |
| Catheter Gauge | 4 French |
| Device Size Text, specify | 0 |
| Length | 10 Centimeter |
| Catheter Gauge | 4 French |
| Device Size Text, specify | 0 |
| Length | 10 Centimeter |
| Catheter Gauge | 4 French |
| Device Size Text, specify | 0 |
| Length | 10 Centimeter |
| Catheter Gauge | 4 French |
| Device Size Text, specify | 0 |
| Length | 10 Centimeter |
| Catheter Gauge | 4 French |
| Device Size Text, specify | 0 |
| Length | 10 Centimeter |
| Catheter Gauge | 4 French |
| Device Size Text, specify | 0 |
| Length | 10 Centimeter |
| Catheter Gauge | 4 French |
| Device Size Text, specify | 0 |
| Length | 10 Centimeter |
| Catheter Gauge | 4 French |
| Device Size Text, specify | 0 |
| Length | 10 Centimeter |
| Catheter Gauge | 4 French |
| Device Size Text, specify | 0 |
| Length | 10 Centimeter |
| Catheter Gauge | 4 French |
| Device Size Text, specify | 0 |
| Length | 10 Centimeter |
| Catheter Gauge | 4 French |
| Device Size Text, specify | 0 |
| Length | 10 Centimeter |
| Catheter Gauge | 4 French |
| Device Size Text, specify | 0 |
| Length | 10 Centimeter |
| Catheter Gauge | 4 French |
| Device Size Text, specify | 0 |
| Length | 10 Centimeter |
| Catheter Gauge | 4 French |
| Device Size Text, specify | 0 |
| Length | 10 Centimeter |
| Catheter Gauge | 4 French |
| Device Size Text, specify | 0 |
| Length | 10 Centimeter |
| Catheter Gauge | 4 French |
| Device Size Text, specify | 0 |
| Length | 10 Centimeter |
| Catheter Gauge | 4 French |
| Device Size Text, specify | 0 |
| Length | 10 Centimeter |
| Catheter Gauge | 4 French |
| Device Size Text, specify | 0 |
| Length | 10 Centimeter |
| Catheter Gauge | 4 French |
| Device Size Text, specify | 0 |
| Length | 10 Centimeter |
| Catheter Gauge | 4 French |
| Device Size Text, specify | 0 |
| Length | 10 Centimeter |
| Catheter Gauge | 4 French |
| Device Size Text, specify | 0 |
| Length | 10 Centimeter |
| Catheter Gauge | 4 French |
| Device Size Text, specify | 0 |
| Length | 10 Centimeter |
| Catheter Gauge | 4 French |
| Device Size Text, specify | 0 |
| Length | 10 Centimeter |
| Catheter Gauge | 4 French |
| Device Size Text, specify | 0 |
| Length | 10 Centimeter |
| Catheter Gauge | 4 French |
| Device Size Text, specify | 0 |
| Length | 10 Centimeter |
| Catheter Gauge | 4 French |
| Device Size Text, specify | 0 |
| Length | 10 Centimeter |
| Catheter Gauge | 4 French |
| Device Size Text, specify | 0 |
| Length | 10 Centimeter |
| Catheter Gauge | 4 French |
| Device Size Text, specify | 0 |
| Length | 10 Centimeter |
| Catheter Gauge | 4 French |
| Device Size Text, specify | 0 |
| Length | 10 Centimeter |
| Catheter Gauge | 4 French |
| Device Size Text, specify | 0 |
| Length | 10 Centimeter |
| Catheter Gauge | 4 French |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00389701007922 [Primary] |
| GS1 | 30389701007923 [Package] Contains: 00389701007922 Package: Shelfbox [10 Units] In Commercial Distribution |
| GS1 | 50389701007927 [Package] Package: Carton [10 Units] In Commercial Distribution |
| DQX | WIRE, GUIDE, CATHETER |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-06-07 |
| Device Publish Date | 2016-09-24 |
| 30389701007954 | GLIDEACCESS System Percutaneous Sheath Introducer Kit |
| 30389701007947 | GLIDEACCESS System Percutaneous Sheath Introducer Kit |
| 50389701007934 | GLIDEACCESS System Percutaneous Sheath Introducer Kit |
| 30389701007923 | GLIDEACCESS System Percutaneous Sheath Introducer Kit |
| 50389701007910 | GLIDEACCESS System Percutaneous Sheath Introducer Kit |
| 50389701007903 | GLIDEACCESS System Percutaneous Sheath Introducer Kit |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() GLIDEACCESS 78636066 3160810 Live/Registered |
Terumo Medical Corporation 2005-05-24 |