Primary Device ID | 10709078014267 |
NIH Device Record Key | ccfebace-959b-42f8-9255-b7eec913a2a3 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | HMEF |
Version Model Number | 010-105564 |
Company DUNS | 092673953 |
Company Name | WESTMED, 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 | true |
Lot Batch | false |
Serial Number | true |
Manufacturing Date | false |
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 | 00709078014260 [Primary] |
GS1 | 10709078014267 [Package] Contains: 00709078014260 Package: [50 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 | 2022-04-08 |
Device Publish Date | 2022-03-31 |
10709078014267 | HMEF Adult In-Line Maxi HMEF W/out Port 350 - 1500 ML VT Range 49.15 ml Dead Space |
10709078014250 | HMEF Adult In-Line Maxi W/Sampling Port 350 - 1500 ML VT Range 49.15 ml Dead Space |
10709078014243 | HMEF Adult Inline Mini W/Sampling Port 150 - 1000 ML VT Range 26.77 ml Dead Space |