SoftTip small 06-00-0716

GUDID 04036616002257

SoftTip small RS-3412 Ohmeda

EnviteC-Wismar GmbH

Pulse oximeter probe, reusable
Primary Device ID04036616002257
NIH Device Record Keyce072263-e742-4db0-ad83-c75964d4b340
Commercial Distribution StatusIn Commercial Distribution
Brand NameSoftTip small
Version Model NumberRS-3412 Ohmeda
Catalog Number06-00-0716
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
GS104036616002257 [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

On-Brand Devices [SoftTip small]

04036616006095SoftTip small RS-3012 Nonin
04036616002301SoftTip small RS-3512-9 Datex
04036616002295SoftTip small RS-3512-40 Datex
04036616002264SoftTip small RS-3412-10 Ohmeda
04036616002257SoftTip small RS-3412 Ohmeda
04036616002202SoftTip small RS-3222-12 BCI
04036616002196SoftTip small RS-3212-9 Nellcor
04036616002172SoftTip small RS-2414-15 HP/Philips
04036616002158SoftTip small RS-2412 HP/Philips
04036616002127SoftTip small RS-2182-3 Minolta

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.