MySign® S 1002217

GUDID 04036616010078

MySign® S incl. R-3211-12 MySign® FDA

EnviteC-Wismar GmbH

Pulse oximeter, battery-powered

• Primary Device ID: 04036616010078
• NIH Device Record Key: 2d17300d-675d-4e6a-97a4-904044cdf85a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MySign® S
• Version Model Number: incl. R-3211-12 MySign® FDA
• Catalog Number: 1002217
• 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: +3841360324
• Email: christian.walsleben@honeywell.com
• Phone: +3841360324
• Email: christian.walsleben@honeywell.com
• Phone: +3841360324
• Email: christian.walsleben@honeywell.com
• Phone: +3841360324
• Email: christian.walsleben@honeywell.com
• Phone: +3841360324
• Email: christian.walsleben@honeywell.com
• Phone: +3841360324
• Email: christian.walsleben@honeywell.com
• Phone: +3841360324
• Email: christian.walsleben@honeywell.com
• Phone: +3841360324
• Email: christian.walsleben@honeywell.com
• Phone: +3841360324
• Email: christian.walsleben@honeywell.com
• Phone: +3841360324
• Email: christian.walsleben@honeywell.com
• Phone: +3841360324
• Email: christian.walsleben@honeywell.com
• Phone: +3841360324
• Email: christian.walsleben@honeywell.com
• Phone: +3841360324
• Email: christian.walsleben@honeywell.com
• Phone: +3841360324
• Email: christian.walsleben@honeywell.com
• Phone: +3841360324
• Email: christian.walsleben@honeywell.com
• Phone: +3841360324
• Email: christian.walsleben@honeywell.com
• Phone: +3841360324
• Email: christian.walsleben@honeywell.com
• Phone: +3841360324
• Email: christian.walsleben@honeywell.com
• Phone: +3841360324
• Email: christian.walsleben@honeywell.com
• Phone: +3841360324
• Email: christian.walsleben@honeywell.com
• Phone: +3841360324
• Email: christian.walsleben@honeywell.com
• Phone: +3841360324
• Email: christian.walsleben@honeywell.com
• Phone: +3841360324
• Email: christian.walsleben@honeywell.com
• Phone: +3841360324
• Email: christian.walsleben@honeywell.com
• Phone: +3841360324
• Email: christian.walsleben@honeywell.com
• Phone: +3841360324
• Email: christian.walsleben@honeywell.com
• Phone: +3841360324
• Email: christian.walsleben@honeywell.com
• Phone: +3841360324
• Email: christian.walsleben@honeywell.com
• Phone: +3841360324
• Email: christian.walsleben@honeywell.com
• Phone: +3841360324
• Email: christian.walsleben@honeywell.com
• Phone: +3841360324
• Email: christian.walsleben@honeywell.com
• Phone: +3841360324
• Email: christian.walsleben@honeywell.com
• Phone: +3841360324
• Email: christian.walsleben@honeywell.com

Device Dimensions

• Length: 166 Millimeter
• Width: 242 Millimeter
• Height: 42 Millimeter
• Length: 166 Millimeter
• Width: 242 Millimeter
• Height: 42 Millimeter
• Length: 166 Millimeter
• Width: 242 Millimeter
• Height: 42 Millimeter
• Length: 166 Millimeter
• Width: 242 Millimeter
• Height: 42 Millimeter
• Length: 166 Millimeter
• Width: 242 Millimeter
• Height: 42 Millimeter
• Length: 166 Millimeter
• Width: 242 Millimeter
• Height: 42 Millimeter
• Length: 166 Millimeter
• Width: 242 Millimeter
• Height: 42 Millimeter
• Length: 166 Millimeter
• Width: 242 Millimeter
• Height: 42 Millimeter
• Length: 166 Millimeter
• Width: 242 Millimeter
• Height: 42 Millimeter
• Length: 166 Millimeter
• Width: 242 Millimeter
• Height: 42 Millimeter
• Length: 166 Millimeter
• Width: 242 Millimeter
• Height: 42 Millimeter
• Length: 166 Millimeter
• Width: 242 Millimeter
• Height: 42 Millimeter
• Length: 166 Millimeter
• Width: 242 Millimeter
• Height: 42 Millimeter
• Length: 166 Millimeter
• Width: 242 Millimeter
• Height: 42 Millimeter
• Length: 166 Millimeter
• Width: 242 Millimeter
• Height: 42 Millimeter
• Length: 166 Millimeter
• Width: 242 Millimeter
• Height: 42 Millimeter
• Length: 166 Millimeter
• Width: 242 Millimeter
• Height: 42 Millimeter
• Length: 166 Millimeter
• Width: 242 Millimeter
• Height: 42 Millimeter
• Length: 166 Millimeter
• Width: 242 Millimeter
• Height: 42 Millimeter
• Length: 166 Millimeter
• Width: 242 Millimeter
• Height: 42 Millimeter
• Length: 166 Millimeter
• Width: 242 Millimeter
• Height: 42 Millimeter
• Length: 166 Millimeter
• Width: 242 Millimeter
• Height: 42 Millimeter
• Length: 166 Millimeter
• Width: 242 Millimeter
• Height: 42 Millimeter
• Length: 166 Millimeter
• Width: 242 Millimeter
• Height: 42 Millimeter
• Length: 166 Millimeter
• Width: 242 Millimeter
• Height: 42 Millimeter
• Length: 166 Millimeter
• Width: 242 Millimeter
• Height: 42 Millimeter
• Length: 166 Millimeter
• Width: 242 Millimeter
• Height: 42 Millimeter
• Length: 166 Millimeter
• Width: 242 Millimeter
• Height: 42 Millimeter
• Length: 166 Millimeter
• Width: 242 Millimeter
• Height: 42 Millimeter
• Length: 166 Millimeter
• Width: 242 Millimeter
• Height: 42 Millimeter
• Length: 166 Millimeter
• Width: 242 Millimeter
• Height: 42 Millimeter
• Length: 166 Millimeter
• Width: 242 Millimeter
• Height: 42 Millimeter
• Length: 166 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04036616010078 [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: 2020-04-24
• Device Publish Date: 2016-09-22

On-Brand Devices [MySign® S]

• 04036616010092: MySign® S incl. F-3211-12 MySign® FDA
• 04036616010085: MySign® S inkl. DA-2211-1 MySign® FDA
• 04036616010078: MySign® S incl. R-3211-12 MySign® FDA
• 04036616009874: MySign® S wo/power supply FDA