MC40

GUDID 08586014620295

EKOM spol. s r.o.

Medical device air compressor Medical device air compressor Medical device air compressor Medical device air compressor Medical device air compressor Medical device air compressor Medical device air compressor Medical device air compressor Medical device air compressor Medical device air compressor Medical device air compressor Medical device air compressor

• Primary Device ID: 08586014620295
• NIH Device Record Key: d1ea24fc-355f-4826-91ee-05bb109133fd
• Commercial Distribution Discontinuation: 2023-06-09
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: MC40
• Version Model Number: 230V/50Hz KARTON
• Company DUNS: 360551766
• Company Name: EKOM spol. s r.o.
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08586014620295 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091871

FDA Product Code

• BTI: Compressor, Air, Portable

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: 2023-06-12
• Device Publish Date: 2016-05-26

Devices Manufactured by EKOM spol. s r.o.

• 08586014620059 - E1: 2023-07-28
• 08586014620066 - E1: 2023-07-28
• 08586014620073 - E1: 2023-07-28
• 08586014620301 - MC40 C: 2023-07-28
• 08586014625047 - DK50 DS: 2023-06-22
• 08586014620295 - MC40: 2023-06-12
• 08586014620295 - MC40: 2023-06-12
• 08586014620905 - DK50 DM: 2023-06-12
• 08586014620912 - DK50 D: 2023-06-12