Primary Device ID | D8063100B1 |
NIH Device Record Key | d6af002b-64f1-4ae6-aa18-b9d5f262e459 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Maytex Face Mask |
Version Model Number | 3100B |
Company DUNS | 196642151 |
Company Name | MAYTEX CORPORATION |
Device Count | 50 |
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 | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
HIBCC | D8063100B0 [Unit of Use] |
HIBCC | D8063100B1 [Primary] |
FXX | Mask, Surgical |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2020-05-06 |
Device Publish Date | 2016-09-23 |
D8063200B1 | Maytex face mask tie on blue |
D8063125W1 | Maytex Silksoft face mask white |
D8063125P1 | Maytex face mask silksoft pink |
D8063125MM1 | Maytex face mask silksoft multi colored |
D8063125G1 | Maytex face mask Silksoft green |
D8063125B1 | Maytex Silksoft face mask blue |
D8063100Y1 | Maytex ear loop mask yellow color |
D8063100W1 | Maytex ear loop mask white color |
D8063100P1 | Maytex ear loop mask pink color |
D8063100MM1 | Maytex face mask multi colored |
D8063100G1 | Maytex ear loop mask green color |
D8063100B1 | 3100B |