FDA.report

Western/Scott Fetzer

Primary DI
B929MDM80
Brand
Western/Scott Fetzer
Company
WESTERN/SCOTT FETZER COMPANY
Model
MDM-8
Catalog number
MDM-8
Device description
EMERGENCY OXYGEN MANIFOLD
Published
2022-08-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
CAXFlowmeter, Tube, Thorpe, Back-Pressure Compensated

Product Code Classifications

CodeDeviceSpecialtyClass
CAXFlowmeter, Tube, Thorpe, Back-Pressure CompensatedAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B929MDM80PrimaryHIBCC0

GMDN Terms

TermDefinition
Medical gas flowmeter, dial-typeA device intended to regulate the flow of a medical gas [e.g., oxygen (O2), carbon dioxide (CO2), nitrous oxide (N2O), helium/oxygen gas mixture (heliox), medical air] during various procedures (e.g., therapeutic administration, anaesthesia, insufflation during surgery). It has a pre-calibrated adjustable flow selection dial intended to control the gas flow rate; it is not intended to provide flow rate measurements. It will be calibrated to a specific medical gas and have a dedicated flow rate range, therefore some types may be dedicated to a specific patient group (e.g., neonate, infant, adult) or clinical use.

Sterilization Methods

Method

Contacts

PhoneEmail
1-800-783-7890SALES@WESTERNENTERPRISES.COM

Regulatory Flags

DUNS number
148634731
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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B929N4OX240FP4FP40Western/Scott FetzerN4OX-240FP4FP4N4OX-240FP4FP42023-10-04
B929CMNDR6000Western/Scott FetzerCMNDR-600CMNDR-6002023-08-11

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