Primary Device ID | 00866035000343 |
NIH Device Record Key | e0f36bb1-17fc-4723-8080-961f7fd7d25e |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Shikani HME |
Version Model Number | S-HME |
Company DUNS | 063502758 |
Company Name | Airway Company, The |
Device Count | 5 |
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 | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | true |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | true |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00866035000343 [Primary] |
GS1 | 10866035000340 [Unit of Use] |
GS1 | 20866035000347 [Package] Package: [5 Units] In Commercial Distribution |
BYD | Condenser, Heat And Moisture (Artificial Nose) |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2019-06-03 |
Device Publish Date | 2019-05-24 |
00866035000305 - Shikani Speaking Valve | 2019-06-03 |
00866035000312 - Shikani Speaking Valve | 2019-06-03 |
00866035000343 - Shikani HME | 2019-06-03 |
00866035000343 - Shikani HME | 2019-06-03 |
00866035000350 - Shikani HME Oxygen Tube | 2019-06-03 |