Primary Device ID | 10841470105294 |
NIH Device Record Key | 0ef6eabb-1da2-4302-b88e-4372d5fdd141 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | VentiSure2 |
Version Model Number | 301-5818 |
Company DUNS | 154502934 |
Company Name | ENGINEERED MEDICAL SYSTEMS INC |
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 |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | 317-246-5500 |
info@engmedsys.com |
Device Size Text, specify | 0 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00841470105297 [Primary] |
GS1 | 10841470105294 [Package] Contains: 00841470105297 Package: [8 Units] In Commercial Distribution |
BTM | Ventilator, Emergency, Manual (Resuscitator) |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2019-11-11 |
Device Publish Date | 2016-09-30 |
10841470106956 | 301-5802 |
10841470105430 | 301-5911 |
10841470105423 | 301-5740 |
00841470105419 | 301-5679 |
10841470105409 | 301-5810 |
00841470105396 | 301-5735 |
10841470105386 | 301-5812 |
10841470105379 | 301-5803 |
10841470105362 | 301-5742 |
10841470105355 | 301-5581 |
10841470105348 | 301-5678 |
10841470105331 | 301-5580 |
10841470105324 | 301-5800 |
10841470105317 | 301-5726 |
10841470105300 | 301-5736 |
10841470105294 | 301-5818 |
10841470105287 | 301-5582 |
10841470105270 | 301-5734 |
10841470105263 | 301-5680 |
10841470105256 | 301-5811 |
10841470105249 | 301-5739 |
10841470105232 | 301-5813 |
10841470105225 | 301-5677 |
10841470105218 | 301-5579 |
10841470105195 | 301-5737 |
10841470105201 | 301-5817 |