| Primary Device ID | 00801741132155 |
| NIH Device Record Key | f360088f-53a5-431b-a3da-e299b9de4091 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AV Sheath Tunneler |
| Version Model Number | AVST3000 |
| Catalog Number | AVST3000 |
| Company DUNS | 135057938 |
| Company Name | Bard Peripheral Vascular, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | 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)321-4254 |
| medical.services@crbard.com | |
| Phone | +1(800)321-4254 |
| medical.services@crbard.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00801741132155 [Primary] |
| MZY | Graft,vascular,stainless steel tunneler |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00801741132155]
Moist Heat or Steam Sterilization
[00801741132155]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-09-19 |
| 00801741132155 | AV Sheath Tunneler |
| 00801741090530 | AV Sheath Tunneler Set |
| 00801741090523 | AV Sheath Tunneler Component, Handle |
| 00801741090516 | AV Sheath Tunneler Sterilization Cassette |