AincA® 00-197

GUDID B005001970

Cuff Pressure Monitor, 0-120cmH2O, w/ Inflation-Bulb/Deflation-Trigger, Vacuum Port, Hook, Ext. Tube

ANESTHESIA ASSOCIATES, INC.

Endotracheal tube cuff inflator Endotracheal tube cuff inflator Endotracheal tube cuff inflator Endotracheal tube cuff inflator Endotracheal tube cuff inflator Endotracheal tube cuff inflator Endotracheal tube cuff inflator Endotracheal tube cuff inflator Endotracheal tube cuff inflator Endotracheal tube cuff inflator Endotracheal tube cuff inflator Endotracheal tube cuff inflator Endotracheal tube cuff inflator Endotracheal tube cuff inflator Endotracheal tube cuff inflator Endotracheal tube cuff inflator

• Primary Device ID: B005001970
• NIH Device Record Key: d64b0c38-0a95-45c8-ad06-3fd9bfb4680a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AincA®
• Version Model Number: 00-197
• Catalog Number: 00-197
• Company DUNS: 002065670
• Company Name: ANESTHESIA ASSOCIATES, INC.
• Device Count: 1
• DM Exempt: true
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B005001970 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K912723

FDA Product Code

• BSK: Cuff, tracheal tube, inflatable

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