Philips 860322

GUDID 00884838000476

Philips Medical Systems

Electrocardiographic ambulatory recorder

• Primary Device ID: 00884838000476
• NIH Device Record Key: c41aefc6-f26f-4108-8ac6-2af341626225
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Philips
• Version Model Number: 860322
• Catalog Number: 860322
• Company DUNS: 078628040
• Company Name: Philips Medical Systems
• 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

Customer Support Contacts

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Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884838000476 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071733

FDA Product Code

• MWJ: ELECTROCARDIOGRAPH,AMBULATORY(WITHOUT ANALYSIS)

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: 2019-11-08
• Device Publish Date: 2016-11-21

On-Brand Devices [Philips]

• 00884838091702: 453564798921
• 00884838091689: 860429
• 00884838087293: 453564659351
• 00884838087286: 453564659341
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• 00884838087262: 453564659321
• 00884838082007: 860354
• 00884838081185: 453564150771
• 00884838081178: 453564150761
• 00884838081123: 860306
• 00884838081116: 860353
• 00884838080836: 453564150751
• 00884838080829: 453564150741
• 00884838032965: 989803157501
• 00884838032958: 989803157491
• 00884838032941: 989803157481
• 00884838032545: 860355
• 00884838032514: 860352
• 00884838030299: 860343
• 00884838029187: 989803180191
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• 00884838029125: 989803180131
• 00884838029118: 989803180121
• 00884838028784: 860332
• 00884838026582: 860315
• 00884838026568: 860310
• 00884838025509: 989803175921
• 00884838025493: 989803175911
• 00884838025486: 989803175901
• 00884838025479: 989803175891
• 00884838015005: 989803151781
• 00884838014992: NA
• 00884838014985: 989803151661
• 00884838014978: 989803151651
• 00884838013162: 989803101691
• 00884838013117: 989803166031
• 00884838013094: 989803164281
• 00884838013070: 989803158481
• 00884838013056: 989803151761
• 00884838013049: 989803151751
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• 00884838012974: 989803151631