DK50 DS

GUDID 08586014625047

EKOM spol. s r.o.

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• Primary Device ID: 08586014625047
• NIH Device Record Key: 87fbb601-aca6-485e-9ab1-10d9198ee24a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DK50 DS
• Version Model Number: BAS NOZ 115V 60Hz 3bar NO MEK
• 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	08586014625047 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-22
• Device Publish Date: 2023-06-14

On-Brand Devices [DK50 DS]

• 08586014621407: 120V/60Hz UL 3bar NO
• 08586014625047: BAS NOZ 115V 60Hz 3bar NO MEK