Bio-Med Devices, Inc. 2002K2

GUDID 00813841020171

Air / Oxygen Blender high flow for CV2

BIO-MED DEVICES, INC.

Oxygen/air breathing gas mixer, hospital

• Primary Device ID: 00813841020171
• NIH Device Record Key: 590ad755-b67f-4f8b-b3be-d243e8522e63
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bio-Med Devices, Inc.
• Version Model Number: 2002K2
• Catalog Number: 2002K2
• Company DUNS: 116167966
• Company Name: BIO-MED DEVICES, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 203-458-0202
• Email: CUSTSERV@BIOMEDDEVICES.COM
• Phone: 203-458-0202
• Email: CUSTSERV@BIOMEDDEVICES.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813841020171 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K925982

FDA Product Code

• MOD: Accessory To Continuous Ventilator (Respirator)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-11-02

On-Brand Devices [Bio-Med Devices, Inc.]

• 00813841021246: Air / Oxygen Blender with 3 ports MR-conditional
• 00813841021239: Air / Oxygen Blender with 3 ports
• 00813841021222: Air / Oxygen Blender low flow MR-conditional
• 00813841021215: Air / Oxygen Blender low flow switching
• 00813841021208: Air / Oxygen Blender low flow with flowmeter
• 00813841021192: Air / Oxygen Blender low flow with flowmeters
• 00813841021185: Air / Oxygen Blender low flow with flowmeters
• 00813841021178: Air / Oxygen Blender low flow with flowmeters
• 00813841021161: Air / Oxygen Blender low flow with flowmeters
• 00813841021154: Air / Oxygen Blender low flow with flowmeters
• 00813841021147: Air / Oxygen Blender low flow with flowmeter
• 00813841021130: Air / Oxygen Blender low flow with flowmeter
• 00813841021123: Air / Oxygen Blender low flow with flowmeter
• 00813841021116: Air / Oxygen Blender low flow
• 00813841021109: Air / Oxygen Blender high flow with flowmeter
• 00813841021093: Air / Oxygen Blender high flow MR-conditional
• 00813841021086: Air / Oxygen Blender high / low flow switching
• 00813841021079: Air / Oxygen Blender high / low flow with flowmeter
• 00813841021062: Air / Oxygen Blender high / low flow
• 00813841021055: Air / Oxygen Blender low flow for Draeger
• 00813841021048: Air / Oxygen Blender low flow for Draeger
• 00813841021031: Infant Ventilator, pneumatic, for Draeger
• 00813841021024: Infant Ventilator, pneumatic, for Draeger
• 00813841021017: Infant Ventilator, pneumatic, for Draeger
• 00813841021000: Ventilator, Transport
• 00813841020997: Ventilator, Transport
• 00813841020959: Air / Oxygen Blender with 3 ports and 2 flowmeters
• 00813841020942: Air / Oxygen Blender with 3 ports and 2 EU flowmeters
• 00813841020935: Air / Oxygen Blender low flow with flowmeters Eurocare
• 00813841020928: Air / Oxygen Blender
• 00813841020911: Infant Ventilator, pneumatic, MR-conditional, complete package
• 00813841020904: Infant Ventilator, pneumatic, MR-conditional
• 00813841020898: Infant Ventilator, pneumatic, for International Biomedical
• 00813841020881: Infant Ventilator, pneumatic, MR-conditional, with blender and flowmeter
• 00813841020874: Adult Ventilator, pneumatic
• 00813841020867: Adult Ventilator, pneumatic
• 00813841020850: Adult Ventilator, pneumatic
• 00813841020843: Ventilator, Transport
• 00813841020836: Ventilator, Transport
• 00813841020829: Ventilator, Transport
• 00813841020812: Ventilator, Transport
• 00813841020805: Ventilator, Transport
• 00813841020799: Ventilator, Transport
• 00813841020782: Ventilator, Transport
• 00813841020775: Ventilator, Transport
• 00813841020768: Ventilator, Transport
• 00813841020751: Ventilator, Transport
• 00813841020744: Ventilator, Transport
• 00813841020737: Ventilator, Transport
• 00813841020720: Ventilator, Transport