FDA.reportPublic FDA data

CLEAR TUBING

Primary DI
00619498149872
Brand
CLEAR TUBING
Company
RESMED PTY LTD
Model
14987
Catalog number
14987
Device description
" TUBING,CLEAR GREY RIBBED, 6'6"" (2 METERS)"
Published
2016-09-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
BYXTubing, Pressure And Accessories
BZDVentilator, Non-Continuous (Respirator)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYXTubing, Pressure And AccessoriesAnesthesiology1
BZDVentilator, Non-Continuous (Respirator)Anesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00619498149872PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00619498149872006194981498726194981498720619498149872

GMDN Terms#

Term, Definition table
TermDefinition
Ventilator breathing circuit, reusableAn assembly of devices designed to conduct air or oxygen (O2) enriched gases and additional gases [e.g., nitrous oxide (N2O), halogenated gases] from a ventilator, or other air-delivery therapeutic device such as a mechanical insufflator/exsufflator, to a patient. It includes breathing tubes, a Y-piece connector, and provides connections for devices that humidify, deliver medication, and monitor gas concentration or pressure within the breathing circuit. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity0 Percent (%) Relative Humidity96 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
Lot or batch
true
No natural rubber latex
true

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Primary DI, Brand, Model table
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