Primary Device ID | 10850025200025 |
NIH Device Record Key | e1601951-f9ae-4902-bc7a-417d45f4575a |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | AIME 1776 |
Version Model Number | GFM12 |
Company DUNS | 117707985 |
Company Name | AIME USA LLC |
Device Count | 50 |
DM Exempt | true |
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 | true |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | false |
Phone | 430-264-3872 |
support@aimeusa.com | |
Phone | 430-264-3872 |
support@aimeusa.com | |
Phone | 430-264-3872 |
support@aimeusa.com | |
Phone | 430-264-3872 |
support@aimeusa.com | |
Phone | 430-264-3872 |
support@aimeusa.com | |
Phone | 430-264-3872 |
support@aimeusa.com | |
Phone | 430-264-3872 |
support@aimeusa.com | |
Phone | 430-264-3872 |
support@aimeusa.com | |
Phone | 430-264-3872 |
support@aimeusa.com | |
Phone | 430-264-3872 |
support@aimeusa.com | |
Phone | 430-264-3872 |
support@aimeusa.com | |
Phone | 430-264-3872 |
support@aimeusa.com | |
Phone | 430-264-3872 |
support@aimeusa.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00850025200028 [Unit of Use] |
GS1 | 10850025200025 [Primary] |
FXX | Mask, Surgical |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2020-12-01 |
Device Publish Date | 2020-11-23 |
10850025200025 | Disposable 3-ply earloop procedure mask |
00850025200011 | Disposable 3-ply earloop procedure mask |