Amron Oxygen Treatment Hood

GUDID 00860010778616

02 VINYL HOOD W/OPTICAL WINDOW, NECK RING ASSEMBLY, UNTRIMMED SILICONE NECK SEAL

Amron International, Inc.

Oxygen administration hood, adult
Primary Device ID00860010778616
NIH Device Record Key0f324e9b-f277-4e00-b6e2-5aebfbc659f2
Commercial Distribution StatusIn Commercial Distribution
Brand NameAmron Oxygen Treatment Hood
Version Model Number8891-03
Company DUNS086003852
Company NameAmron International, Inc.
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone7602086589
Emaildlynch@amronintl.com
Phone7602086589
Emaildlynch@amronintl.com
Phone7602086589
Emaildlynch@amronintl.com
Phone7602086589
Emaildlynch@amronintl.com
Phone7602086589
Emaildlynch@amronintl.com
Phone7602086589
Emaildlynch@amronintl.com
Phone7602086589
Emaildlynch@amronintl.com
Phone7602086589
Emaildlynch@amronintl.com
Phone7602086589
Emaildlynch@amronintl.com
Phone7602086589
Emaildlynch@amronintl.com
Phone7602086589
Emaildlynch@amronintl.com
Phone7602086589
Emaildlynch@amronintl.com
Phone7602086589
Emaildlynch@amronintl.com
Phone7602086589
Emaildlynch@amronintl.com
Phone7602086589
Emaildlynch@amronintl.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100860010778616 [Primary]

FDA Product Code

FOGHood, Oxygen, Infant

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-01-07
Device Publish Date2024-12-30

On-Brand Devices [Amron Oxygen Treatment Hood]

0086001077860902 VINYL HOOD W/OPTICAL WINDOW, NECK RING ASSEMBLY, STRAPS AND UNTRIMMED SILICONE NECK SEAL
0086001077861602 VINYL HOOD W/OPTICAL WINDOW, NECK RING ASSEMBLY, UNTRIMMED SILICONE NECK SEAL

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