Top Safety

GUDID 04719871891605

Pocket Mask in Hard Case with Clip

FOREMOUNT ENTERPRISE CO., LTD.

Resuscitator face mask, single-use
Primary Device ID04719871891605
NIH Device Record Key249a5e9f-2813-4834-9b12-c47582e517bc
Commercial Distribution StatusIn Commercial Distribution
Brand NameTop Safety
Version Model Number05-605-555AWN
Company DUNS658718465
Company NameFOREMOUNT ENTERPRISE CO., LTD.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104719871891605 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CBPValve, Non-Rebreathing

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-07-08
Device Publish Date2024-06-28

On-Brand Devices [Top Safety]

04719871891896Pocket Mask in Small Hard Case
04719871891605Pocket Mask in Hard Case with Clip
04719871891001Pocket Mask Combo Pack- Zip Bag
04719871890912Pocket Mask Combo Pack-Hard Case in Red
04719871890905Pocket Mask Combo Pack
04719871890899Adult / Child & Infant Masks in a Red Bag
04719871890882Pocket Mask in Hard Case
04719871890875Pocket Mask in Hard Case
047198718907212 in 1 Valve
04719871890714Pocket Mask

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.