MADA MEDICAL PRODUCTS, INC 1531E

GUDID 00815160020153

A container designed as a refillable cylinder with an integrated pressure regulator used to hold compressed medical oxygen (O2) under safe conditions at high pressure (e.g., 50 - 200 Bar). It is typically NOT filled with O2 when delivered from the gas supplier and includes a built-in pressure regulator that, when activated, releases the O2 at the correct working pressure. It is available in some cylinder sizes (capacity) and color-coded to denote O2 content. The cylinder may be made of steel, aluminum (Al) or other ferrous or non-ferrous materials. O2 is used as an essential life support gas, for anesthesia, and for therapeutic purposes

MADA MEDICAL PRODUCTS, INC

Fixed-regulator oxygen cylinder

• Primary Device ID: 00815160020153
• NIH Device Record Key: 4d65b646-c976-480c-9518-487733382463
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MADA MEDICAL PRODUCTS, INC
• Version Model Number: 1531E
• Catalog Number: 1531E
• Company DUNS: 048411862
• Company Name: MADA MEDICAL PRODUCTS, INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (201)460-0454
• Email: dianelind@madamedical.com
• Phone: (201)460-0454
• Email: dianelind@madamedical.com
• Phone: (201)460-0454
• Email: dianelind@madamedical.com
• Phone: (201)460-0454
• Email: dianelind@madamedical.com
• Phone: (201)460-0454
• Email: dianelind@madamedical.com
• Phone: (201)460-0454
• Email: dianelind@madamedical.com
• Phone: (201)460-0454
• Email: dianelind@madamedical.com
• Phone: (201)460-0454
• Email: dianelind@madamedical.com
• Phone: (201)460-0454
• Email: dianelind@madamedical.com
• Phone: (201)460-0454
• Email: dianelind@madamedical.com
• Phone: (201)460-0454
• Email: dianelind@madamedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815160020153 [Primary]

FDA Product Code

• CAN: Regulator, Pressure, Gas Cylinder

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2015-10-26

On-Brand Devices [MADA MEDICAL PRODUCTS, INC]

• 00815160020207: A container designed as a refillable cylinder with an integrated pressure regulator used to hold
• 00815160020153: A container designed as a refillable cylinder with an integrated pressure regulator used to hold