PRIMACARE

GUDID 06970691000266

BLOOD PRESSURE MONITOR WITH STETHOSCOPE

Wuxi Exanovo Medical Instrument Co., Ltd.

Aneroid manual sphygmomanometer

• Primary Device ID: 06970691000266
• NIH Device Record Key: 03c1e299-58f9-43cc-81f9-643c19db5097
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PRIMACARE
• Version Model Number: DS-9195
• Company DUNS: 541561271
• Company Name: Wuxi Exanovo Medical Instrument Co., Ltd.
• 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	06970691000266 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203620

FDA Product Code

• DXQ: Blood Pressure Cuff

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-04-18
• Device Publish Date: 2023-04-10

On-Brand Devices [PRIMACARE]

• 06970691000266: BLOOD PRESSURE MONITOR WITH STETHOSCOPE
• 06970691000259: BLOOD PRESSURE MONITOR WITH STETHOSCOPE
• 06970691000242: BLOOD PRESSURE MONITOR WITH STETHOSCOPE
• 06970691000235: BLOOD PRESSURE KIT WITH SPRAGUE RAPPAPORT STETHOSCOPE
• 06970691000228: BLOOD PRESSURE KIT WITH SPRAGUE RAPPAPORT STETHOSCOPE
• 06970691000211: BLOOD PRESSURE MONITOR WITH STETHOSCOPE,BLACK
• 06970691000273: BLOOD PRESSURE KIT,FANNY PACK