Wyltec

GUDID 00852333007191

Aneroid Sphygmomanometer

3J'S HEALTHCARE GROUP LLC

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• Primary Device ID: 00852333007191
• NIH Device Record Key: 4736c421-8e9f-4d01-b7b6-9c73ed881069
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Wyltec
• Version Model Number: W03-01001BLK
• Company DUNS: 080425823
• Company Name: 3J'S HEALTHCARE GROUP LLC
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852333007191 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082542

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: 2017-12-20