Antistatic Compact Space Chamber with Small Mask

GUDID 00842135100015

MEDICAL DEVELOPMENTS INTERNATIONAL LIMITED

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• Primary Device ID: 00842135100015
• NIH Device Record Key: 33d584ef-f2ec-4eeb-bacb-53b6d6ce876d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Antistatic Compact Space Chamber with Small Mask
• Version Model Number: SP-ANTI-SSUS
• Company DUNS: 751908968
• Company Name: MEDICAL DEVELOPMENTS INTERNATIONAL LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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

Operating and Storage Conditions

• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842135100015 [Primary]
GS1	10842135100012 [Package]; Package: outer carton [24 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143615

FDA Product Code

• NVP: Holding Chambers, Direct Patient Interface

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: 2023-09-25
• Device Publish Date: 2017-04-13

On-Brand Devices [Antistatic Compact Space Chamber with Small Mask]

• 10842135100012: SP-ANTI-SSUS
• 00842135100015: SP-ANTI-SSUS