AincA 00-325-MRI-LP

GUDID B00500325MRILP0

Jet Ventilator Replacement Hose, MRI, Outlet

ANESTHESIA ASSOCIATES, INC.

Respiratory oxygen therapy system

• Primary Device ID: B00500325MRILP0
• NIH Device Record Key: 33455928-bd69-4713-9154-3b6df857767f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AincA
• Version Model Number: 00-325-MRI-LP
• Catalog Number: 00-325-MRI-LP
• Company DUNS: 002065670
• Company Name: ANESTHESIA ASSOCIATES, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (760) 744-6561
• Email: Solutions@AincA.com
• Phone: (760) 744-6561
• Email: Solutions@AincA.com
• Phone: (760) 744-6561
• Email: Solutions@AincA.com
• Phone: (760) 744-6561
• Email: Solutions@AincA.com
• Phone: (760) 744-6561
• Email: Solutions@AincA.com
• Phone: (760) 744-6561
• Email: Solutions@AincA.com
• Phone: (760) 744-6561
• Email: Solutions@AincA.com
• Phone: (760) 744-6561
• Email: Solutions@AincA.com
• Phone: (760) 744-6561
• Email: Solutions@AincA.com
• Phone: (760) 744-6561
• Email: Solutions@AincA.com
• Phone: (760) 744-6561
• Email: Solutions@AincA.com
• Phone: (760) 744-6561
• Email: Solutions@AincA.com
• Phone: (760) 744-6561
• Email: Solutions@AincA.com
• Phone: (760) 744-6561
• Email: Solutions@AincA.com
• Phone: (760) 744-6561
• Email: Solutions@AincA.com
• Phone: (760) 744-6561
• Email: Solutions@AincA.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B00500325MRILP0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K921926

FDA Product Code

• BTL: Ventilator, Emergency, Powered (Resuscitator)

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: 2016-08-19

On-Brand Devices [AincA]

• B005004900: Adapter, Mask Elbow, CPAP w/Pop-Off, 15mmM x 22mmM/15mmF x1/4", Chrome Brass
• B005004880: Adapter, Mask Elbow , CPAP w/ Pop-Off, 15mmM x 22mmM/15mmF, 1/4" x 1/4", Chrome Brass
• B00500452P0: Adapter, Mask Elbow w/ Pop-Off, 15mmM x 22mmM/15mmF, Conductive Neoprene
• B00500452IP0: Adapter, Mask Elbow w/ Inlet & Pop-Off, 15mmM x 22mmM/15mmF x 5/16", Conductive Neoprene
• B00500451P0: Adapter, Catheter 'Y' w/ Pop-Off, 7/8" x 7/8" x 22mmM/15mmF, Conductive Neoprene
• B00500450P0: Adapter, Chimney 'Y' w/ Pop-Off, 7/8" x 7/8" x 22mmM/15mmF, Conductive Neoprene
• B005004370: Adapter, Mask, Rendell-Baker Chimney w/ Pop-Off, 7/8" x 15mmM x 5/16", Chrome Plated Brass
• B005004220: Valve, Non-Rebreathing, 90°, Adjustable, 22mmM/15mmF x 7/8", Chrome Brass
• B005004200: Valve, Non-Rebreathing, Stephen Slater, 15mmM x 15mmF x Thumb Check, Chrome Brass
• B005004000: Valve, Bag-Tail Pop-Off, Straight, 3/8'', Aluminum
• B005003980: Valve, Pop-off, Pediatric, 3/8-24 , Chrome Brass
• B005003970: Valve, Bag-Tail Pop-Off, True APL, 0-55 cmH20, 3/8", Delrin / Brass
• B005003950: Valve, Bag-Tail Pop-Off, Palm Type, 3/8", Acrylic / Brass
• B005003940: Valve, Bag-Tail Pop-Off, 90° Type, w/ Evacuator, 3/8" x 3/8'', Acrylic / Brass
• B005003930: Valve, Bag-Tail Pop-Off, Palm Type, w/ Evacuator, 3/8" x 3/8'', Acrylic / Brass
• B00500379S0: Evacuator, Gas, In-line, w/ Pop-Off, 15mmM x 15mmF x 19mmM Suction x 1/4'' Port, Delrin
• B005003790: Evacuator, Gas, In-line, w/ Pop-Off, 15mmM x 15mmF x 1/4'' Suction, Delrin
• B00500325S0: Jet Ventilator Assembly, Custom
• B00500325MRIS0: Jet Ventilator Assembly, MR Conditional, Custom
• B00500325MRILPS0: Jet Ventilator Replacement Hose, MRI, Outlet, Custom
• B00500325MRILP0: Jet Ventilator Replacement Hose, MRI, Outlet
• B00500325MRIHPS0: Jet Ventilator Replacement Hose, MRI, Inlet, Custom
• B00500325MRIHP0: Jet Ventilator Replacement Hose, MRI, Inlet
• B00500325MRI0: Jet Ventilator Assembly, MR Conditional
• B00500325LPS0: Jet Ventilator Replacement Hose, Outlet, Custom
• B00500325LPEXT40: Jet Ventilator Extension Hose, 4 foot long
• B00500325LPEXT20: Jet Ventilator Extension Hose, 2 foot long
• B00500325LP0: Jet Ventilator Replacement Hose, Outlet
• B00500325HPS0: Jet Ventilator Replacement Hose, Inlet, Custom
• B00500325HP0: Jet Ventilator Replacement Hose, Inlet
• B005003250: Jet Ventilator Assembly, Standard
• B00500274MRI0: MRI Manometer w/ Adj. Pressure Relief Valve & Pole Clamp, 1/4" Inlet, MRI Cond. 3.0 Tesla
• B00500274MAX0: Manometer, Pressure, Max Hold, -40 to +80 cm H20, w/ APL Relief Valve x 1/4" Inlet
• B005002740: Manometer, Pressure, -40 to +80 cm H20, w/ APL Relief Valve x 1/4" Inlet Tube
• B00500273MRI0: Valve, Pressure Relief, 0-55 cmH20 True APL, 1/2-20 thd, Brass, MRI Cond. 3.0 Tesla
• B005002730: Valve, Pressure Relief, 0-55 cmH20 True APL, 1/2-20, Chrome Brass
• B00500251D0: Valve, In-line Relief, 0-55 cmH20 True APL, 15mmF x 15mmM, Black Delrin
• B005002510: Valve, In-line Relief, 0-55 cmH20 True APL, 15mmF x 15mmM, Chrome Brass
• B005002500: Valve, In-Line Relief, 0-55 cmH20 True APL, 22mmF X 22mmM/15mmF, Chrome Brass
• B005002470: Adapter, Mask Elbow, w/Pop-Off, 22mmM x 22mmM/15mmF, Aluminum
• B00500233P0: Adapter, Mask Elbow w/ Pop-Off Valve, Aluminum
• B005002290: Adapter, Mask Elbow, CPAP w/Pop-Off, Aluminum
• B005002230: Adapter, Mask Elbow, w/Pop-Off, Clear Plastic
• B00500251DMRI0: Valve, In-Line "T", 0-60 cm H2O Adjustable True APL Valve, MRI Cond 3T, 15mmF x 15mmM, Delrin/Br