SoftTip® large 1002302

GUDID 04036616010245

SoftTip® large R-2203-16 AMC

EnviteC-Wismar GmbH

Pulse oximeter probe, reusable

• Primary Device ID: 04036616010245
• NIH Device Record Key: fad8a083-d305-44c1-acda-1bfc563cf7ea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SoftTip® large
• Version Model Number: R-2203-16 AMC
• Catalog Number: 1002302
• Company DUNS: 330943838
• Company Name: EnviteC-Wismar GmbH
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +493841360324
• Email: christian.walsleben@honeywell.com
• Phone: +493841360324
• Email: christian.walsleben@honeywell.com
• Phone: +493841360324
• Email: christian.walsleben@honeywell.com
• Phone: +493841360324
• Email: christian.walsleben@honeywell.com
• Phone: +493841360324
• Email: christian.walsleben@honeywell.com
• Phone: +493841360324
• Email: christian.walsleben@honeywell.com
• Phone: +493841360324
• Email: christian.walsleben@honeywell.com
• Phone: +493841360324
• Email: christian.walsleben@honeywell.com
• Phone: +493841360324
• Email: christian.walsleben@honeywell.com
• Phone: +493841360324
• Email: christian.walsleben@honeywell.com
• Phone: +493841360324
• Email: christian.walsleben@honeywell.com
• Phone: +493841360324
• Email: christian.walsleben@honeywell.com
• Phone: +493841360324
• Email: christian.walsleben@honeywell.com
• Phone: +493841360324
• Email: christian.walsleben@honeywell.com
• Phone: +493841360324
• Email: christian.walsleben@honeywell.com
• Phone: +493841360324
• Email: christian.walsleben@honeywell.com
• Phone: +493841360324
• Email: christian.walsleben@honeywell.com
• Phone: +493841360324
• Email: christian.walsleben@honeywell.com
• Phone: +493841360324
• Email: christian.walsleben@honeywell.com
• Phone: +493841360324
• Email: christian.walsleben@honeywell.com
• Phone: +493841360324
• Email: christian.walsleben@honeywell.com
• Phone: +493841360324
• Email: christian.walsleben@honeywell.com
• Phone: +493841360324
• Email: christian.walsleben@honeywell.com
• Phone: +493841360324
• Email: christian.walsleben@honeywell.com
• Phone: +493841360324
• Email: christian.walsleben@honeywell.com
• Phone: +493841360324
• Email: christian.walsleben@honeywell.com
• Phone: +493841360324
• Email: christian.walsleben@honeywell.com
• Phone: +493841360324
• Email: christian.walsleben@honeywell.com
• Phone: +493841360324
• Email: christian.walsleben@honeywell.com
• Phone: +493841360324
• Email: christian.walsleben@honeywell.com
• Phone: +493841360324
• Email: christian.walsleben@honeywell.com
• Phone: +493841360324
• Email: christian.walsleben@honeywell.com
• Phone: +493841360324
• Email: christian.walsleben@honeywell.com
• Phone: +493841360324
• Email: christian.walsleben@honeywell.com
• Phone: +493841360324
• Email: christian.walsleben@honeywell.com
• Phone: +493841360324
• Email: christian.walsleben@honeywell.com
• Phone: +493841360324
• Email: christian.walsleben@honeywell.com
• Phone: +493841360324
• Email: christian.walsleben@honeywell.com
• Phone: +493841360324
• Email: christian.walsleben@honeywell.com
• Phone: +493841360324
• Email: christian.walsleben@honeywell.com
• Phone: +493841360324
• Email: christian.walsleben@honeywell.com
• Phone: +493841360324
• Email: christian.walsleben@honeywell.com
• Phone: +493841360324
• Email: christian.walsleben@honeywell.com

Device Dimensions

• Length: 140 Millimeter
• Height: 40 Millimeter
• Width: 130 Millimeter
• Length: 140 Millimeter
• Height: 40 Millimeter
• Width: 130 Millimeter
• Length: 140 Millimeter
• Height: 40 Millimeter
• Width: 130 Millimeter
• Length: 140 Millimeter
• Height: 40 Millimeter
• Width: 130 Millimeter
• Length: 140 Millimeter
• Height: 40 Millimeter
• Width: 130 Millimeter
• Length: 140 Millimeter
• Height: 40 Millimeter
• Width: 130 Millimeter
• Length: 140 Millimeter
• Height: 40 Millimeter
• Width: 130 Millimeter
• Length: 140 Millimeter
• Height: 40 Millimeter
• Width: 130 Millimeter
• Length: 140 Millimeter
• Height: 40 Millimeter
• Width: 130 Millimeter
• Length: 140 Millimeter
• Height: 40 Millimeter
• Width: 130 Millimeter
• Length: 140 Millimeter
• Height: 40 Millimeter
• Width: 130 Millimeter
• Length: 140 Millimeter
• Height: 40 Millimeter
• Width: 130 Millimeter
• Length: 140 Millimeter
• Height: 40 Millimeter
• Width: 130 Millimeter
• Length: 140 Millimeter
• Height: 40 Millimeter
• Width: 130 Millimeter
• Length: 140 Millimeter
• Height: 40 Millimeter
• Width: 130 Millimeter
• Length: 140 Millimeter
• Height: 40 Millimeter
• Width: 130 Millimeter
• Length: 140 Millimeter
• Height: 40 Millimeter
• Width: 130 Millimeter
• Length: 140 Millimeter
• Height: 40 Millimeter
• Width: 130 Millimeter
• Length: 140 Millimeter
• Height: 40 Millimeter
• Width: 130 Millimeter
• Length: 140 Millimeter
• Height: 40 Millimeter
• Width: 130 Millimeter
• Length: 140 Millimeter
• Height: 40 Millimeter
• Width: 130 Millimeter
• Length: 140 Millimeter
• Height: 40 Millimeter
• Width: 130 Millimeter
• Length: 140 Millimeter
• Height: 40 Millimeter
• Width: 130 Millimeter
• Length: 140 Millimeter
• Height: 40 Millimeter
• Width: 130 Millimeter
• Length: 140 Millimeter
• Height: 40 Millimeter
• Width: 130 Millimeter
• Length: 140 Millimeter
• Height: 40 Millimeter
• Width: 130 Millimeter
• Length: 140 Millimeter
• Height: 40 Millimeter
• Width: 130 Millimeter
• Length: 140 Millimeter
• Height: 40 Millimeter
• Width: 130 Millimeter
• Length: 140 Millimeter
• Height: 40 Millimeter
• Width: 130 Millimeter
• Length: 140 Millimeter
• Height: 40 Millimeter
• Width: 130 Millimeter
• Length: 140 Millimeter
• Height: 40 Millimeter
• Width: 130 Millimeter
• Length: 140 Millimeter
• Height: 40 Millimeter
• Width: 130 Millimeter
• Length: 140 Millimeter
• Height: 40 Millimeter
• Width: 130 Millimeter
• Length: 140 Millimeter
• Height: 40 Millimeter
• Width: 130 Millimeter
• Length: 140 Millimeter
• Height: 40 Millimeter
• Width: 130 Millimeter
• Length: 140 Millimeter
• Height: 40 Millimeter
• Width: 130 Millimeter
• Length: 140 Millimeter
• Height: 40 Millimeter
• Width: 130 Millimeter
• Length: 140 Millimeter
• Height: 40 Millimeter
• Width: 130 Millimeter
• Length: 140 Millimeter
• Height: 40 Millimeter
• Width: 130 Millimeter
• Length: 140 Millimeter
• Height: 40 Millimeter
• Width: 130 Millimeter
• Length: 140 Millimeter
• Height: 40 Millimeter
• Width: 130 Millimeter
• Length: 140 Millimeter
• Height: 40 Millimeter
• Width: 130 Millimeter
• Length: 140 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04036616010245 [Primary]

FDA Product Code

• DQA: Oximeter

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-04-30
• Device Publish Date: 2016-09-22

On-Brand Devices [SoftTip® large]

• 04036616010245: SoftTip® large R-2203-16 AMC
• 04036616010009: SoftTip® large R-3212-9 MySign® FDA
• 04036616009898: SoftTip® large R-3211-12 MySign® FDA
• 04036616009881: SoftTip® large R-3211-31 MySign® FDA
• 04036616005678: SoftTip® large R-2414-30 HP/Philips
• 04036616001854: SoftTip® large R-2203-16 Nihon Kohden
• 04036616001830: SoftTip® large R-2182-3 Minolta