Primary Device ID | 00896506002088 |
NIH Device Record Key | 8636e5d6-3a53-435d-a2de-494d724ffe3a |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Spiration Valve System |
Version Model Number | HUS-V5 |
Company DUNS | 117521967 |
Company Name | Gyrus Acmi, Inc. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | MR Conditional |
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 | false |
OTC Over-The-Counter | false |
Outer Diameter | 5 Millimeter |
Outer Diameter | 5 Millimeter |
Outer Diameter | 5 Millimeter |
Outer Diameter | 5 Millimeter |
Outer Diameter | 5 Millimeter |
Outer Diameter | 5 Millimeter |
Outer Diameter | 5 Millimeter |
Outer Diameter | 5 Millimeter |
Outer Diameter | 5 Millimeter |
Outer Diameter | 5 Millimeter |
Outer Diameter | 5 Millimeter |
Outer Diameter | 5 Millimeter |
Outer Diameter | 5 Millimeter |
Outer Diameter | 5 Millimeter |
Outer Diameter | 5 Millimeter |
Outer Diameter | 5 Millimeter |
Outer Diameter | 5 Millimeter |
Outer Diameter | 5 Millimeter |
Outer Diameter | 5 Millimeter |
Outer Diameter | 5 Millimeter |
Outer Diameter | 5 Millimeter |
Outer Diameter | 5 Millimeter |
Outer Diameter | 5 Millimeter |
Outer Diameter | 5 Millimeter |
Outer Diameter | 5 Millimeter |
Outer Diameter | 5 Millimeter |
Outer Diameter | 5 Millimeter |
Outer Diameter | 5 Millimeter |
Outer Diameter | 5 Millimeter |
Outer Diameter | 5 Millimeter |
Outer Diameter | 5 Millimeter |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00896506002088 [Primary] |
OAZ | One-Way Air-Leak Valve |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2021-03-04 |
Device Publish Date | 2014-09-23 |
00896506002217 | Airway Sizing Kit |
00896506002200 | Valve in Cartridge, 9mm |
00896506002187 | Deployment Catheter and Loader, 2.6 |
00896506002125 | Airway Sizing Kit |
00896506002118 | Deployment Catheter and Loader, 2.6 |
00896506002101 | Valve in Cartridge, 7mm |
00896506002095 | Valve in Cartridge, 6mm |
00896506002088 | Valve in Cartridge , 5mm |