FDA.report

Mask, Face, w/o Valve, Infant

Primary DI
00817081025972
Brand
Mask, Face, w/o Valve, Infant
Company
A-M SYSTEMS, LLC
Model
Mask, Face, w/o Valve, Infant - 167400
Catalog number
167400
Device description
Mask, Face, w/o Valve, Infant
Published
2020-03-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
BYGMask, Oxygen

Product Code Classifications

CodeDeviceSpecialtyClass
BYGMask, OxygenAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00817081025972PackageGS120In Commercial Distribution
00817081025965PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00817081025972008170810259728170810259720817081025972
00817081025965008170810259658170810259650817081025965

GMDN Terms

TermDefinition
Rebreathing oxygen face maskA non-sterile, flexible, form-shaped device designed to be placed over the nose and mouth to deliver a proportional mixture of air/oxygen (O2) to a patient's airway. It is made of non-conductive, soft, flexible polymers available in a range of sizes, and designed to create an airtight seal against the patient's face. The device may include tubing and various valves and connectors which may allow for connection to a central vacuum system to enable scavenging of residual (waste) anaesthetic gas from a patient in recovery; other respiratory equipment (e.g., nebulizer, humidifier, CPAP device) is not included. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
3606838300sales@a-msystems.com

Regulatory Flags

DUNS number
020275145
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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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