Prime Series 1125-000-026

GUDID 07613327278316

STRYKER CORPORATION

Hospital stretcher, powered

• Primary Device ID: 07613327278316
• NIH Device Record Key: ca6107b3-2bc0-4bc8-b419-5c54e405529e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Prime Series
• Version Model Number: 1125
• Catalog Number: 1125-000-026
• Company DUNS: 078470558
• Company Name: STRYKER CORPORATION
• Device Count: 1
• DM Exempt: false
• 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: 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 -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327278316 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140095

FDA Product Code

• INK: STRETCHER, WHEELED, POWERED

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

On-Brand Devices [Prime Series]

• 07613327356090: 1115EHT3
• 07613327347463: 1105MHT1
• 07613327278330: 1115
• 07613327278323: 1125
• 07613327278316: 1125
• 07613327278293: 1125
• 07613327278286: 1125
• 07613327278279: 1105
• 07613327278255: 1115
• 07613327278248: 1115
• 07613327278231: 1115
• 07613327278224: 1105
• 07613327278217: 1115
• 07613327278194: 1105
• 07613327278156: 1105
• 07613327278149: 1105
• 07613327623482: 111505550004
• 07613327623475: 111505550002
• 07613327623468: 112505550001
• 07613327623451: 111505550001
• 07613327623444: 111505550003
• 07613327623437: 112505550001
• 07613327622690: 1105-000-000C
• 07613327613650: 1125-000-000C
• 07613327613643: 1115-000-000C