Disposable sensor 1002324

GUDID 04036616010207

Disposable Sensor DA-2203-1 Nihon Kohden US

EnviteC-Wismar GmbH

Pulse oximeter probe, single-use

• Primary Device ID: 04036616010207
• NIH Device Record Key: eab5e106-6d2d-4602-a2c6-d53f95591369
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Disposable sensor
• Version Model Number: DA-2203-1 Nihon Kohden US
• Catalog Number: 1002324
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Height: 130 Millimeter
• Width: 200 Millimeter
• Length: 200 Millimeter
• Height: 130 Millimeter
• Width: 200 Millimeter
• Length: 200 Millimeter
• Height: 130 Millimeter
• Width: 200 Millimeter
• Length: 200 Millimeter
• Height: 130 Millimeter
• Width: 200 Millimeter
• Length: 200 Millimeter
• Height: 130 Millimeter
• Width: 200 Millimeter
• Length: 200 Millimeter
• Height: 130 Millimeter
• Width: 200 Millimeter
• Length: 200 Millimeter
• Height: 130 Millimeter
• Width: 200 Millimeter
• Length: 200 Millimeter
• Height: 130 Millimeter
• Width: 200 Millimeter
• Length: 200 Millimeter
• Height: 130 Millimeter
• Width: 200 Millimeter
• Length: 200 Millimeter
• Height: 130 Millimeter
• Width: 200 Millimeter
• Length: 200 Millimeter
• Height: 130 Millimeter
• Width: 200 Millimeter
• Length: 200 Millimeter
• Height: 130 Millimeter
• Width: 200 Millimeter
• Length: 200 Millimeter
• Height: 130 Millimeter
• Width: 200 Millimeter
• Length: 200 Millimeter
• Height: 130 Millimeter
• Width: 200 Millimeter
• Length: 200 Millimeter
• Height: 130 Millimeter
• Width: 200 Millimeter
• Length: 200 Millimeter
• Height: 130 Millimeter
• Width: 200 Millimeter
• Length: 200 Millimeter
• Height: 130 Millimeter
• Width: 200 Millimeter
• Length: 200 Millimeter
• Height: 130 Millimeter
• Width: 200 Millimeter
• Length: 200 Millimeter
• Height: 130 Millimeter
• Width: 200 Millimeter
• Length: 200 Millimeter
• Height: 130 Millimeter
• Width: 200 Millimeter
• Length: 200 Millimeter
• Height: 130 Millimeter
• Width: 200 Millimeter
• Length: 200 Millimeter
• Height: 130 Millimeter
• Width: 200 Millimeter
• Length: 200 Millimeter
• Height: 130 Millimeter
• Width: 200 Millimeter
• Length: 200 Millimeter
• Height: 130 Millimeter
• Width: 200 Millimeter
• Length: 200 Millimeter
• Height: 130 Millimeter
• Width: 200 Millimeter
• Length: 200 Millimeter
• Height: 130 Millimeter
• Width: 200 Millimeter
• Length: 200 Millimeter
• Height: 130 Millimeter
• Width: 200 Millimeter
• Length: 200 Millimeter
• Height: 130 Millimeter
• Width: 200 Millimeter
• Length: 200 Millimeter
• Height: 130 Millimeter
• Width: 200 Millimeter
• Length: 200 Millimeter
• Height: 130 Millimeter
• Width: 200 Millimeter
• Length: 200 Millimeter
• Height: 130 Millimeter
• Width: 200 Millimeter
• Length: 200 Millimeter
• Height: 130 Millimeter
• Width: 200 Millimeter
• Length: 200 Millimeter

Operating and Storage Conditions

• Handling Environment Temperature: Between 5 Millimeter of Mercury and 40 Millimeter of Mercury
• 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 Millimeter of Mercury and 40 Millimeter of Mercury
• 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 Millimeter of Mercury and 40 Millimeter of Mercury
• 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 Millimeter of Mercury and 40 Millimeter of Mercury
• 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 Millimeter of Mercury and 40 Millimeter of Mercury
• 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 Millimeter of Mercury and 40 Millimeter of Mercury
• 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 Millimeter of Mercury and 40 Millimeter of Mercury
• 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 Millimeter of Mercury and 40 Millimeter of Mercury
• 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 Millimeter of Mercury and 40 Millimeter of Mercury
• 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 Millimeter of Mercury and 40 Millimeter of Mercury
• 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 Millimeter of Mercury and 40 Millimeter of Mercury
• 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 Millimeter of Mercury and 40 Millimeter of Mercury
• 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 Millimeter of Mercury and 40 Millimeter of Mercury
• 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 Millimeter of Mercury and 40 Millimeter of Mercury
• 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 Millimeter of Mercury and 40 Millimeter of Mercury
• 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 Millimeter of Mercury and 40 Millimeter of Mercury
• 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 Millimeter of Mercury and 40 Millimeter of Mercury
• 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 Millimeter of Mercury and 40 Millimeter of Mercury
• 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 Millimeter of Mercury and 40 Millimeter of Mercury
• 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 Millimeter of Mercury and 40 Millimeter of Mercury
• 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 Millimeter of Mercury and 40 Millimeter of Mercury
• 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 Millimeter of Mercury and 40 Millimeter of Mercury
• 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 Millimeter of Mercury and 40 Millimeter of Mercury
• 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 Millimeter of Mercury and 40 Millimeter of Mercury
• 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 Millimeter of Mercury and 40 Millimeter of Mercury
• 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 Millimeter of Mercury and 40 Millimeter of Mercury
• 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 Millimeter of Mercury and 40 Millimeter of Mercury
• 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 Millimeter of Mercury and 40 Millimeter of Mercury
• 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 Millimeter of Mercury and 40 Millimeter of Mercury
• 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 Millimeter of Mercury and 40 Millimeter of Mercury
• 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 Millimeter of Mercury and 40 Millimeter of Mercury
• 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 Millimeter of Mercury and 40 Millimeter of Mercury
• 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	04036616010207 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K992215

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: 2021-11-10
• Device Publish Date: 2016-09-22

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