FDA.reportPublic FDA data

SoftTip large

Primary DI
04036616001908
Brand
SoftTip large
Company
Honeywell Healthcare Solutions GmbH
Model
R-3212-9 Nellcor
Catalog number
06-00-0711
Device description
SoftTip large R-3212-9 Nellcor
Published
2016-09-22
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
DQAOximeter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQAOximeterCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04036616001908PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04036616001908040366160019084036616001908

GMDN Terms#

Term, Definition table
TermDefinition
Pulse oximeter probe, reusableA photoelectric device applied externally to a body site, e.g., a fingertip, ear lobe, the bridge of nose, a toe, or the bridge of the foot of a paediatric or adult patient for the transcutaneous measurement of haemoglobin oxygen saturation (SpO2) in arterial blood using light detection. The signals, typically produced by light-emitting diodes (LEDs) and a receiving detector, are received by an oximeter to which this device is connected. The oximeter displays the SpO2 values and may calculate/display other parameters, e.g., electrocardiogram (ECG). This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height40Millimeter
Length140Millimeter
Width130Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature5 Degrees Celsius40 Degrees Celsius
Storage Environment Humidity15 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
330943838
Device count
1
DM exempt
true
Serial number
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04036616010948Oxygen SensorOOMLF102-M3E10026032020-03-03
04036616013895Oxygen SensorOOM113-ME10029542025-11-12
04036616010856Oxygen SensorOOMLF111-HE10025382025-04-28
04036616013871Oxygen SensorOOMLF204-DE10029522025-04-28
04036616000581Disposable SensorDA-2221-1 BCI08-00-01232016-09-22
04036616007146Disposable SensorDA-2221-1 OEM BCI08-00-03232016-09-22
04036616010207Disposable sensorDA-2203-1 Nihon Kohden US10023242016-09-22
04036616001939SoftTip largeR-3212-31 Nellcor06-00-07092016-09-22
04036616001946SoftTip largeR-3222-12 BCI06-00-05842016-09-22
04036616002066SoftTip largeR-3512-40 Datex06-00-07272016-09-22
04036616002073SoftTip largeR-3512-9 Datex06-00-07662016-09-22
04036616002127SoftTip smallRS-2182-3 Minolta06-00-05912016-09-22
04036616002158SoftTip smallRS-2412 HP/Philips06-00-07262016-09-22
04036616002202SoftTip smallRS-3222-12 BCI06-00-05832016-09-22
04036616002257SoftTip smallRS-3412 Ohmeda06-00-07162016-09-22
04036616002264SoftTip smallRS-3412-10 Ohmeda06-00-08222016-09-22
04036616002295SoftTip smallRS-3512-40 Datex06-00-07292016-09-22
04036616002301SoftTip smallRS-3512-9 Datex06-00-08152016-09-22
04036616002349SoftTip® mediumRM-2182-3 Minolta06-00-13612016-09-22
04036616002370SoftTip® mediumRM-2412 HP/Phillips06-00-13642016-09-22

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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