Primary Device ID | 04961333247318 |
NIH Device Record Key | 8a60cfed-fea6-443f-845e-fa7a766c8c97 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | NASOMETER |
Version Model Number | 6500 |
Company DUNS | 083211284 |
Company Name | PENTAX OF AMERICA, 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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 04961333247318 [Primary] |
KLX | Electroglottograph |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2019-06-17 |
Device Publish Date | 2019-06-07 |
04961333247318 | NASOMETER |
04961333247301 | NASOMETER SOFTWARE |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
NASOMETER 98045631 not registered Live/Pending |
Kahn, Sandra 2023-06-16 |