Internal Handle

GUDID 00847946020835

ASSY, MAIH, 2.0 DIA, 7 FT, W/SWITCH, 100-240V, PACKAGED, English

Zoll Medical Corporation

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• Primary Device ID: 00847946020835
• NIH Device Record Key: 3960b1c9-0252-40b5-ae60-d02424f0a8c1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Internal Handle
• Version Model Number: 1003-1141-05
• Company DUNS: 055363428
• Company Name: Zoll Medical Corporation
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00847946020835 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042302

FDA Product Code

• LDD: Dc-defibrillator, low-energy, (including paddles)

Sterilization

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

[00847946020835]

Dry Heat Sterilization

[00847946020835]

Dry Heat Sterilization

[00847946020835]

Dry Heat Sterilization

[00847946020835]

Dry Heat Sterilization

[00847946020835]

Dry Heat Sterilization

[00847946020835]

Dry Heat Sterilization

[00847946020835]

Dry Heat Sterilization

[00847946020835]

Dry Heat Sterilization

[00847946020835]

Dry Heat Sterilization

[00847946020835]

Dry Heat Sterilization

[00847946020835]

Dry Heat Sterilization

[00847946020835]

Dry Heat Sterilization

[00847946020835]

Dry Heat Sterilization

[00847946020835]

Dry Heat Sterilization

[00847946020835]

Dry Heat Sterilization

[00847946020835]

Dry Heat Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-30

On-Brand Devices [Internal Handle]

• 00847946023003: 1011-0141-05-16
• 00847946022990: 1011-0141-05-11
• 00847946022983: 1011-0141-05-10
• 00847946022976: 1011-0141-05-08
• 00847946022969: 1011-0141-05-02
• 00847946022952: 1011-0141-05
• 00847946022945: 1011-0141-04-16
• 00847946022938: 1011-0141-04-11
• 00847946022921: 1011-0141-04-10
• 00847946022914: 1011-0141-04-08
• 00847946022907: 1011-0141-04-02
• 00847946022891: 1011-0141-04
• 00847946022884: 1011-0141-03-16
• 00847946022877: 1011-0141-03-11
• 00847946022860: 1011-0141-03-10
• 00847946022853: 1011-0141-03-08
• 00847946022846: 1011-0141-03-02
• 00847946022839: 1011-0141-03
• 00847946022822: 1011-0141-02-16
• 00847946022815: 1011-0141-02-11
• 00847946022808: 1011-0141-02-10
• 00847946022792: 1011-0141-02-08
• 00847946022785: 1011-0141-02-02
• 00847946022778: 1011-0141-02
• 00847946022761: 1011-0141-01-16
• 00847946022754: 1011-0141-01-11
• 00847946022747: 1011-0141-01-10
• 00847946022730: 1011-0141-01-08
• 00847946022723: 1011-0141-01-02
• 00847946022716: 1011-0141-01
• 00847946022709: 1011-0140-05-16
• 00847946022693: 1011-0140-05-11
• 00847946022686: 1011-0140-05-10
• 00847946022679: 1011-0140-05-08
• 00847946022662: 1011-0140-05-02
• 00847946022655: 1011-0140-04-16
• 00847946022648: 1011-0140-04-11
• 00847946022631: 1011-0140-04-10
• 00847946022624: 1011-0140-04-08
• 00847946022617: 1011-0140-04-02
• 00847946022600: 1011-0140-03-16
• 00847946022594: 1011-0140-03-11
• 00847946022587: 1011-0140-03-10
• 00847946022570: 1011-0140-03-08
• 00847946022563: 1011-0140-03-02
• 00847946022556: 1011-0140-02-16
• 00847946022549: 1011-0140-02-11
• 00847946022532: 1011-0140-02-10
• 00847946022525: 1011-0140-02-08
• 00847946022518: 1011-0140-02-02