FDA.reportPublic FDA data

Apnealink

Primary DI
00619498223749
Brand
Apnealink
Company
RESMED LIMITED
Model
22374
Catalog number
22374
Device description
XPOD 3012 LP Oximeter
Published
2018-07-31
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

Product Codes#

Code, Name table
CodeName
MNRVentilatory Effort Recorder

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNRVentilatory Effort RecorderAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00619498223749PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00619498223749006194982237496194982237490619498223749

GMDN Terms#

Term, Definition table
TermDefinition
Pulse oximeter, line-poweredA mains electricity (AC-powered) photoelectric device intended for the continuous transcutaneous measurement and display of haemoglobin oxygen saturation (SpO2). The signals, typically produced by light-emitting diodes (LEDs) and a receiving detector in a probe, or directly built-in, are used to make the measurements using the principle of spectrophotometry. The oximeter displays the SpO2 values and may calculate/display other parameters, e.g., pulse rate, electrocardiogram (ECG). The device is typically used bedside.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity5 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-25 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
751149311
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00619498390014AIR 1139001390012021-06-25
00619498390021AIR 1139002390022021-06-25
00619498390038AIR 1139003390032021-06-25
00619498390045AIR 1139004390042021-06-25
00619498390052AIR 1139005390052021-06-25
00619498393022AIR 1139302393022021-06-25
00619498393039AIR 1139303393032021-06-25
00619498393046AIR 1139304393042021-06-25
00619498393053AIR 1139305393052021-06-25
00619498393060AIR 1139306393062021-06-25
00619498393077AIR 1139307393072021-06-25
00619498629442AirFit P1062944629442021-05-06
00619498629459AirFit P1062945629452021-05-06
00619498394203AIR 1139300393002021-03-31
00619498391004HUMIDAIR11 STANDARD39100391002021-03-31
00619498003273CLIMATELINEAIR 1139102391022021-03-31
00619498392056AIR 1139205392052021-03-31
00619498392209AIR 1139220392202021-03-31
00619498393008AIR 1139300393002021-03-31
00619498393015AIR 1139301393012021-03-31

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09342451002754Compumedics FalconCOMPUMEDICS LIMITEDMNR2026-03-12
09342451002822Compumedics SomfitCOMPUMEDICS LIMITEDMNR2026-03-12
09342451002860Compumedics SomfitCOMPUMEDICS LIMITEDMNR2026-03-12
09342451007063Compumedics Somfit DCOMPUMEDICS LIMITEDMNR2026-03-12
00840067104224CadwellCADWELL INDUSTRIES, INC.MNR2026-03-02
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00382830026765NatusXLTEKMNR2025-02-27
00382830027236NatusXLTEKMNR2025-02-27
00382830027243NatusXLTEKMNR2025-02-27
00382830027250NatusXLTEKMNR2025-02-27
00382830059244NatusXLTEKMNR2025-02-27