MC40 C

GUDID 08586014620301

EKOM spol. s r.o.

Medical device air compressor

• Primary Device ID: 08586014620301
• NIH Device Record Key: 40edffdf-6d28-427a-8d07-e69b8f943b56
• Commercial Distribution Discontinuation: 2018-09-26
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: MC40 C
• Version Model Number: 230V/50Hz KAR
• 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	08586014620301 [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: 2023-07-28
• 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
• 08586014620301 - MC40 C: 2023-07-28
• 08586014625047 - DK50 DS: 2023-06-22
• 08586014620295 - MC40: 2023-06-12
• 08586014620905 - DK50 DM: 2023-06-12
• 08586014620912 - DK50 D: 2023-06-12