AincA® 00-115-S

GUDID B00500115S0

Arm, Universal Control, Single Tube System, Gauge, Bag Nipple, 22mmMx15mmF Outlet, w/00-118 APL Valve

ANESTHESIA ASSOCIATES, INC.

Anaesthesia breathing circuit, reusable

• Primary Device ID: B00500115S0
• NIH Device Record Key: 623689bf-83a7-467e-bb87-40829998e112
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AincA®
• Version Model Number: 00-115-S
• Catalog Number: 00-115-S
• Company DUNS: 002065670
• Company Name: ANESTHESIA ASSOCIATES, INC.
• 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: 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: +1(760)744-6561
• Email: Solutions@AincA.com
• Phone: +1(760)744-6561
• Email: Solutions@AincA.com
• Phone: +1(760)744-6561
• Email: Solutions@AincA.com
• Phone: +1(760)744-6561
• Email: Solutions@AincA.com
• Phone: +1(760)744-6561
• Email: Solutions@AincA.com
• Phone: +1(760)744-6561
• Email: Solutions@AincA.com
• Phone: +1(760)744-6561
• Email: Solutions@AincA.com
• Phone: +1(760)744-6561
• Email: Solutions@AincA.com
• Phone: +1(760)744-6561
• Email: Solutions@AincA.com
• Phone: +1(760)744-6561
• Email: Solutions@AincA.com
• Phone: +1(760)744-6561
• Email: Solutions@AincA.com
• Phone: +1(760)744-6561
• Email: Solutions@AincA.com
• Phone: +1(760)744-6561
• Email: Solutions@AincA.com
• Phone: +1(760)744-6561
• Email: Solutions@AincA.com
• Phone: +1(760)744-6561
• Email: Solutions@AincA.com
• Phone: +1(760)744-6561
• Email: Solutions@AincA.com
• Phone: +1(760)744-6561
• Email: Solutions@AincA.com
• Phone: +1(760)744-6561
• Email: Solutions@AincA.com
• Phone: +1(760)744-6561
• Email: Solutions@AincA.com
• Phone: +1(760)744-6561
• Email: Solutions@AincA.com
• Phone: +1(760)744-6561
• Email: Solutions@AincA.com
• Phone: +1(760)744-6561
• Email: Solutions@AincA.com
• Phone: +1(760)744-6561
• Email: Solutions@AincA.com
• Phone: +1(760)744-6561
• Email: Solutions@AincA.com
• Phone: +1(760)744-6561
• Email: Solutions@AincA.com
• Phone: +1(760)744-6561
• Email: Solutions@AincA.com
• Phone: +1(760)744-6561
• Email: Solutions@AincA.com
• Phone: +1(760)744-6561
• Email: Solutions@AincA.com
• Phone: +1(760)744-6561
• Email: Solutions@AincA.com
• Phone: +1(760)744-6561
• Email: Solutions@AincA.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B00500115S0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K833871

FDA Product Code

• CAI: Circuit, breathing (w connector, adaptor, y piece)

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: 2021-04-08
• Device Publish Date: 2021-03-31

On-Brand Devices [AincA®]

• B005P219MRI0: Gauge, Pressure, Replacement, MRI Cond 3T, 0-60 psi, 1/8" NPT-M Bottom, 1.5" Dia, for 00-325-MRI
• B005P2190: Gauge, Pressure, Replacement, 0-60 PSI, 1/8" NPT-M Bottom-Mount, 1.5" Dia, for 00-325 Jet Vent
• B005P178S0: Tubing, Blood Pressure, 1/4" ID X 1/8" Wall, Non-Conductive, Latex
• B005P1780: Tubing, Blood Pressure, 3/16" ID x 3/32" Wall, Non-Conductive, Latex, per Foot
• B005P159MRI0: Adapter, "T", 1/4 NPT-F x 1/2-20 x 1/4" Tube, MRI Conditional 3.0 Tesla, Brass
• B005P1590: Adapter, "T", 1/4 NPT-F x 1/2-20 x 1/4" Tube, Chrome Plated Brass
• B005P158MAX0: Manometer, Crystal w/ Max Hold Pointer, fits 00-199/274/275 Manometers, Factory Installation Nee
• B005P158L0: Manometer, Crystal Replacement, Fits Current (Post 2013 year) 00-199, 00-274, 00-275 type Gauges
• B005P1580: Manometer, Crystal Replacement, Fits Pre 2013 year 00-199, 00-274, 00-275 type Gauges
• B005LF5580: Bulb w/ Valve, BP Inflation, Large Size
• B005LF5570: Bulb (Only), BP Inflation, Large Size
• B005LF522L0: Stethoscope, Binaural, Extra Long 36", LuerF Lock
• B005LF5220: Stethoscope, Binaural, Extra Long 36", LuerF
• B005LF5180: Bulb w/ Valve, BP Inflation, Standard Size
• B005LF4980: Bulb (Only), BP Inflation, Standard Size
• B005LF390600: Mask, Laryngeal Airway, UltraFlex EX, Size 6.0 (9.4mmID), 15mmM, 40xReusable-Reinforced, Silicon
• B005LF390500: Mask, Laryngeal Airway, UltraFlex EX, Size 5.0 (9.4mmID), 15mmM, 40xReusable-Reinforced, Silicon
• B005LF390400: Mask, Laryngeal Airway, UltraFlex EX, Size 4.0 (9.0mmID), 15mmM, 40xReusable-Reinforced, Silicon
• B005LF390300: Mask, Laryngeal Airway, UltraFlex EX, Size 3.0 (9.0mmID), 15mmM, 40xReusable-Reinforced, Silicon
• B005LF390250: Mask, Laryngeal Airway, UltraFlex EX, Size 2.5 (8.0mmID), 15mmM, 40xReusable-Reinforced, Silicon
• B005LF390200: Mask, Laryngeal Airway, UltraFlex EX, Size 2.0 (6.4mmID), 15mmM, 40xReusable-Reinforced, Silicon
• B005LF390150: Mask, Laryngeal Airway, UltraFlex EX, Size 1.5 (5.9mmID), 15mmM, 40xReusable-Reinforced, Silicon
• B005LF390100: Mask, Laryngeal Airway, UltraFlex EX, Size 1.0 (5.9mmID), 15mmM, 40xReusable-Reinforced, Silicon
• B005LF380600: Mask, Laryngeal Airway, Ultra EX, Size6.0 (11.0mmID), 15mmM, 40xReusable, Silicone
• B005LF380500: Mask, Laryngeal Airway, Ultra EX, Size5.0 (11.0mmID), 15mmM, 40xReusable, Silicone
• B005LF380400: Mask, Laryngeal Airway, Ultra EX, Size4.0 (10.0mmID), 15mmM, 40xReusable, Silicone
• B005LF380300: Mask, Laryngeal Airway, Ultra EX, Size3.0 (10.0mmID), 15mmM, 40xReusable, Silicone
• B005LF380250: Mask, Laryngeal Airway, Ultra EX, Size2.5 (8.5mmID), 15mmM, 40xReusable, Silicone
• B005LF380200: Mask, Laryngeal Airway, Ultra EX, Size2.0 (7.0mmID), 15mmM, 40xReusable, Silicone
• B005LF380150: Mask, Laryngeal Airway, Ultra EX, Size1.5 (6.0mmID), 15mmM, 40xReusable, Silicone
• B005LF380100: Mask, Laryngeal Airway, Ultra EX, Size1.0 (5.0mmID), 15mmM, 40xReusable, Silicone
• B005LF3080: Connector, Flexible, 22mmF x 15mmF, Silicone
• B005LF3070: Connector, Flexible, 22mmF x 22mmF, Silicone
• B005LF217390: Connector, Evacuation, Flexible EPDM Corrugated Tubing, 39" Long, 19mmF x 19mmF Cuffed Ends
• B005LF217300: Connector, Evacuation, Flexible EPDM Corrugated Tubing, 30" Long, 19mmF x 19mmF Cuffed Ends
• B005LF217100: Connector, Evacuation, Flexible EPDM Corrugated Tubing, 10" Long, 19mmF x 19mmF Cuffed Ends
• B005LF1920: Spray, Laryngeal, Swerdlow Type, 6" Straight Adjustable Tip Spray, 2cc Reservoir, w/Reamer-Flush
• B005LF1910: Spray, Laryngeal, Forrester Type, Curved Tip, Fixed Spray, 2cc Reservoir
• B005LF1900: Spray, Laryngeal, Macintosh Type, Flexible Tip, Fixed Spray, 2cc Reservoir
• B005LF178ROLL500: Tubing, Blood Pressure, 3/16" ID x 3/32" Wall, Non-Conductive, 50 Foot Roll
• B005LF1780: Tubing, Blood Pressure, 3/16" ID x 3/32" Wall, Non-Conductive, per Foot
• B005LF17250: Mask, Face, Ambu Type Clear, Inflatable Cuff Seal, 22mmF, Size 5 Adult, Silicone/PC (see 00-333-
• B005LF17240: Mask, Face, Ambu Type Clear, Inflatable Cuff Seal, 22mmF, Size 3-4 Med, Silicone/PC (see 00-333-
• B005LF17220: Mask, Face, Ambu Type Clear, Inflatable Cuff Seal, 22mmF, Size 2 Child, Silicone/PC (see 00-333-
• B005LF1720A0: Mask, Face, Ambu Type Clear, Inflatable Cuff Seal, 15mmM, Size 0 Infant, Silicone/PC
• B005LF17200: Mask, Face, Ambu Type Clear, Inflatable Cuff Seal, 22mmF, Size 0 Infant, Silicone/PC (see 00-333
• B005LF15730: Mask, RBS Type, Pediatric-Fit Seal, 22mmF w/Hook Ring, Size 3 Child, Clear Silicone
• B005LF15720: Mask, RBS Type, Pediatric-Fit Seal, 22mmF, Size 2 Small Child, Clear Silicone
• B005LF15710: Mask, RBS Type, Pediatric-Fit Seal, 22mmF, Size 1 Infant, Clear Silicone
• B005LF15700: Mask, RBS Type, Pediatric-Fit Seal, 22mmF, Size 0 Premature, Clear Silicone