MERITS

GUDID 04714379292916

MERITS HEALTH PRODUCTS CO., LTD.

Wheelchair, power-assisted, occupant-controlled, non-collapsible

• Primary Device ID: 04714379292916
• NIH Device Record Key: e0a80873-f14f-4d47-a0de-cbb718cebbf9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MERITS
• Version Model Number: P321B-SGMUB
• Company DUNS: 657231924
• Company Name: MERITS HEALTH PRODUCTS 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: false
• Serial Number: true
• Manufacturing Date: true
• 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	04714379292916 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K011687

FDA Product Code

• ITI: Wheelchair, Powered

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: 2020-01-24
• Device Publish Date: 2020-01-16

On-Brand Devices [MERITS]

• 04714379292459: E60423YLMUB
• 04714379292442: P31233WRMAB
• 04714379292435: P31233LBMAB
• 04714379292428: P3017-SDMU
• 04714379292411: P3017-SBMU
• 04714379292404: P3017-ARMU
• 04714379292398: P325 30500746
• 04714379292381: S546-2SWMUB
• 04714379292374: S546--SWMUB
• 04714379292367: P325 30200594
• 04714379292350: P325 30200592
• 04714379292343: P323 30200601
• 04714379292336: P323 30200600
• 04714379292329: P3276-ARMUB
• 04714379292312: P326ACARMUB
• 04714379292305: P325 30200589
• 04714379292299: P32033SBMUB
• 04714379292282: P32033ARMUB
• 04714379292275: P3102-SBMUB
• 04714379292268: P3102-ARMUB
• 04714379292251: P31233LBMA
• 04714379292244: P31233WRMA
• 04714379292237: P321B-ARMUB
• 04714379292220: P321A-ARMUB
• 04714379292213: P3271-ARMUB
• 04714379292206: S741A-ARMUB
• 04714379292190: S731A-ARMUB
• 04714379292183: P326ABARMUB
• 04714379292176: P326AAARMUB
• 04714379292169: P3271-SBMU
• 04714379292152: P3271-ARMU
• 04714379292145: P323 30200576
• 04714379292138: P323 30200568
• 04714379292121: P323 30200561
• 04714379292114: B330—BRMU
• 04714379292060: P325 30200560
• 04714379292053: P325 30200552
• 04714379292046: P325 30200554
• 04714379292039: P325 30200553
• 04714379292022: P325 30200545
• 04714379292015: E60421YLMUB
• 04714379292008: E60411YLMUB
• 04714379291995: S731-1ARMUB
• 04714379291988: B211-3BRMU
• 04714379291971: 30300712
• 04714379291940: S331-1ARMU
• 04714379291933: P326D1ARMUB
• 04714379291926: P322-BARMUB
• 04714379291902: E6031-DRMUB
• 04714379291896: E6031-BRMUB