Primary Device ID | 04035479079055 |
NIH Device Record Key | 9e27b971-a4f4-403e-bbaf-d61b6d05844a |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | S 85-G OTW |
Version Model Number | 346979 |
Catalog Number | 346979 |
Company DUNS | 315620229 |
Company Name | BIOTRONIK SE & Co. KG |
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 |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | +1(888)345-0374 |
jon.brumbaugh@biotronik.com | |
Phone | +1(888)345-0374 |
jon.brumbaugh@biotronik.com | |
Phone | +1(888)345-0374 |
jon.brumbaugh@biotronik.com | |
Phone | +1(888)345-0374 |
jon.brumbaugh@biotronik.com | |
Phone | +1(888)345-0374 |
jon.brumbaugh@biotronik.com | |
Phone | +1(888)345-0374 |
jon.brumbaugh@biotronik.com | |
Phone | +1(888)345-0374 |
jon.brumbaugh@biotronik.com | |
Phone | +1(888)345-0374 |
jon.brumbaugh@biotronik.com | |
Phone | +1(888)345-0374 |
jon.brumbaugh@biotronik.com | |
Phone | +1(888)345-0374 |
jon.brumbaugh@biotronik.com | |
Phone | +1(888)345-0374 |
jon.brumbaugh@biotronik.com | |
Phone | +1(888)345-0374 |
jon.brumbaugh@biotronik.com | |
Phone | +1(888)345-0374 |
jon.brumbaugh@biotronik.com | |
Phone | +1(888)345-0374 |
jon.brumbaugh@biotronik.com | |
Phone | +1(888)345-0374 |
jon.brumbaugh@biotronik.com | |
Phone | +1(888)345-0374 |
jon.brumbaugh@biotronik.com | |
Phone | +1(888)345-0374 |
jon.brumbaugh@biotronik.com | |
Phone | +1(888)345-0374 |
jon.brumbaugh@biotronik.com |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Device Issuing Agency | Device ID |
---|---|
GS1 | 04035479079055 [Package] Contains: 04035479145224 Package: case [10 Units] In Commercial Distribution |
GS1 | 04035479145224 [Primary] |
DRB | STYLET, CATHETER |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2019-10-28 |
Device Publish Date | 2014-08-14 |
04035479187163 - Home Monitoring Service Center | 2024-09-11 |
04035479186005 - NEO | 2024-06-25 |
04035479186012 - PSW | 2024-06-25 |
04035479052515 - PK-222 US/2,8m | 2024-06-06 |
04035479186128 - Home Monitoring Service Center | 2024-06-06 |
04035479184575 - BIOTRONIK | 2024-02-28 |
04035479116644 - Selectra | 2024-01-25 |
04035479184285 - NEO | 2023-12-25 |