FDA.reportPublic FDA data

NV UM FFM

Primary DI
00619498002610
Brand
NV UM FFM
Company
RESMED LIMITED
Model
60647
Catalog number
60647
Device description
NV UM FFM SYS LGE STD
Published
2020-05-14
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
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
BYGMask, Oxygen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYGMask, OxygenAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00619498002610Direct MarkingGS10
00619498606429PrimaryGS10
00619498606436PrimaryGS10
00619498606443PrimaryGS10
00619498606450PrimaryGS10
00619498606467PrimaryGS10
00619498606474PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00619498002610006194980026106194980026100619498002610
00619498606429006194986064296194986064290619498606429
00619498606436006194986064366194986064360619498606436
00619498606443006194986064436194986064430619498606443
00619498606450006194986064506194986064500619498606450
00619498606467006194986064676194986064670619498606467
00619498606474006194986064746194986064740619498606474

GMDN Terms#

Term, Definition table
TermDefinition
CPAP/BPAP face mask, reusableA flexible, form-shaped device designed to be placed over a user's nose and mouth to interface with a continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BPAP) unit to provide the respiratory tract with direct ambient air, or medical oxygen (O2) and air, at a higher pressure than ambient air for noninvasive positive pressure ventilation (NPPV). It is typically made of plastic and/or silicone materials that create an airtight seal around the nose and mouth. It is available in various designs and sizes and stabilized with a headstrap. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity0 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-4 Degrees Fahrenheit140 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-424-0737reception@resmed.com

Regulatory Flags#

DUNS number
751149311
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00619498394203AIR 1139300393002021-03-31
00619498003273CLIMATELINEAIR 1139102391022021-03-31
00619498002931MIRAGE QUATTRO16129161292019-01-22
00619498002948MIRAGE QUATTRO16131161312019-01-22
00619498002924QUATTRO AIR16127161272018-11-16
00619498002375QUATTRO AIR16128161282018-11-16
00619498002290MIRAGE QUATTRO16130161302018-11-16
00619498002955QUATTRO AIR16132161322018-11-16
00619498002344QUATTRO AIR16133161332018-11-16
00619498002962AIRFIT F 1016134161342018-11-16
00619498002979AIRFIT F2016135161352018-11-16
00619498002429AIRFIT F2016136161362018-11-16
00619498002986AIRFIT F2016137161372018-11-16
00619498002320MIRAGE FX16140161402018-11-16
00619498002627NV QUATTRO FX61748617482018-11-16
00619498003006AIRFIT N30i63821638212018-11-15
00619498002412AIRFIT N 1016138161382018-10-26
00619498002900AIRFIT N2016141161412018-10-26
00619498002443AIRFIT N2016142161422018-10-26
00619498002917AIRFIT N2016143161432018-10-26

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