SoftTip large 06-00-0709

GUDID 04036616001939

SoftTip large R-3212-31 Nellcor

EnviteC-Wismar GmbH

Pulse oximeter probe, reusable
Primary Device ID04036616001939
NIH Device Record Key07e756c8-f690-44cf-96cd-17c99bc1996b
Commercial Distribution StatusIn Commercial Distribution
Brand NameSoftTip large
Version Model NumberR-3212-31 Nellcor
Catalog Number06-00-0709
Company DUNS330943838
Company NameEnviteC-Wismar GmbH
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Width130 Millimeter
Height40 Millimeter
Length140 Millimeter
Width130 Millimeter
Height40 Millimeter
Length140 Millimeter
Width130 Millimeter
Height40 Millimeter
Length140 Millimeter
Width130 Millimeter
Height40 Millimeter
Length140 Millimeter
Width130 Millimeter
Height40 Millimeter
Length140 Millimeter
Width130 Millimeter
Height40 Millimeter
Length140 Millimeter
Width130 Millimeter
Height40 Millimeter
Length140 Millimeter
Width130 Millimeter
Height40 Millimeter
Length140 Millimeter
Width130 Millimeter
Height40 Millimeter
Length140 Millimeter
Width130 Millimeter
Height40 Millimeter
Length140 Millimeter
Width130 Millimeter
Height40 Millimeter
Length140 Millimeter
Width130 Millimeter
Height40 Millimeter
Length140 Millimeter
Width130 Millimeter
Height40 Millimeter
Length140 Millimeter
Width130 Millimeter
Height40 Millimeter
Length140 Millimeter
Width130 Millimeter
Height40 Millimeter
Length140 Millimeter
Width130 Millimeter
Height40 Millimeter
Length140 Millimeter
Width130 Millimeter
Height40 Millimeter
Length140 Millimeter
Width130 Millimeter
Height40 Millimeter
Length140 Millimeter
Width130 Millimeter
Height40 Millimeter
Length140 Millimeter
Width130 Millimeter
Height40 Millimeter
Length140 Millimeter
Width130 Millimeter
Height40 Millimeter
Length140 Millimeter
Width130 Millimeter
Height40 Millimeter
Length140 Millimeter
Width130 Millimeter
Height40 Millimeter
Length140 Millimeter
Width130 Millimeter
Height40 Millimeter
Length140 Millimeter
Width130 Millimeter
Height40 Millimeter
Length140 Millimeter
Width130 Millimeter
Height40 Millimeter
Length140 Millimeter
Width130 Millimeter
Height40 Millimeter
Length140 Millimeter
Width130 Millimeter
Height40 Millimeter
Length140 Millimeter
Width130 Millimeter
Height40 Millimeter
Length140 Millimeter
Width130 Millimeter
Height40 Millimeter
Length140 Millimeter
Width130 Millimeter
Height40 Millimeter
Length140 Millimeter
Width130 Millimeter
Height40 Millimeter
Length140 Millimeter
Width130 Millimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104036616001939 [Primary]

FDA Product Code

DQAOximeter

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-04-30
Device Publish Date2016-09-22

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04036616002035SoftTip large R-3412-10 Ohmeda
04036616002028SoftTip large R-3412 Ohmeda
04036616001946SoftTip large R-3222-12 BCI
04036616001939SoftTip large R-3212-31 Nellcor
04036616001908SoftTip large R-3212-9 Nellcor
04036616001885SoftTip large R-2414-15 HP/Philips
04036616001861SoftTip large R-2412 HP/Philips

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