RELION 004017283

GUDID 00605388878113

Self Taking Blood Pressure Kit

WAL-MART STORES, INC.

Aneroid manual sphygmomanometer

• Primary Device ID: 00605388878113
• NIH Device Record Key: 8a2506f6-c45d-4c12-9962-48ece36c3090
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RELION
• Version Model Number: 100-021REL
• Catalog Number: 004017283
• Company DUNS: 051957769
• Company Name: WAL-MART STORES, INC.
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00605388878113 [Primary]
GS1	10605388878110 [Package]; Package: [24 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092245

FDA Product Code

• DXQ: Blood Pressure Cuff

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: 2016-09-22

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• 10862212000301: WMTPX-110
• 06945630107252: 33 Gauge
• 06945630101526: 30 Gauge
• 06945630101427: 26 Gauge
• 06945630101229: 30 Gauge
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