ARROW IAP-0400I

GUDID 30801902092060

AUTOCAT2 ITALIAN

TELEFLEX INCORPORATED

Intra-aortic balloon pump

• Primary Device ID: 30801902092060
• NIH Device Record Key: f9bb8c48-3ff0-444e-9850-d9bc77262646
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ARROW
• Version Model Number: IPN000307
• Catalog Number: IAP-0400I
• Company DUNS: 002348191
• Company Name: TELEFLEX INCORPORATED
• 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: 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store between -15 - 40°C (5 - 104°F)
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store between -15 - 40°C (5 - 104°F)
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store between -15 - 40°C (5 - 104°F)
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store between -15 - 40°C (5 - 104°F)
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store between -15 - 40°C (5 - 104°F)
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store between -15 - 40°C (5 - 104°F)
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store between -15 - 40°C (5 - 104°F)
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store between -15 - 40°C (5 - 104°F)
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store between -15 - 40°C (5 - 104°F)
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store between -15 - 40°C (5 - 104°F)
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store between -15 - 40°C (5 - 104°F)
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store between -15 - 40°C (5 - 104°F)
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store between -15 - 40°C (5 - 104°F)
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store between -15 - 40°C (5 - 104°F)
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store between -15 - 40°C (5 - 104°F)
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00801902092069 [Direct Marking]
GS1	30801902092060 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060309

FDA Product Code

• DSP: System, balloon, intra-aortic and control

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2021-01-20
• Device Publish Date: 2015-10-16

On-Brand Devices [ARROW]

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• 00801902136718: FiberOptix Ultra 8 IAB: 8Fr 40cc
• 00801902136701: UltraFlex IAB: 7.5Fr 30cc
• 00801902136695: UltraFlex IAB: 7.5Fr 40cc
• 30801902111549: Arrow(R) Access Kit for use with 5 Fr. Peripherally Inserted Central Venous Catheter
• 30801902111532: Arrow(R) Access Kit for use with 4 Fr. Peripherally Inserted Central Venous Catheter
• 30801902111525: Pressure Injectable ARROWg+ard Blue PLUS(R) Multi-Lumen Central Venous Catheterization Kit
• 30801902111471: Arrow(R) VPS(R) Access Kit for use with 4 Fr. Peripherally Inserted Central Venous Catheter
• 30801902111464: Arrow(R) VPS(R) Access Kit for use with 5 Fr. Peripherally Inserted Central Venous Catheter
• 30801902111457: Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology
• 30801902111440: Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology
• 30801902111433: Peritoneal Lavage Kit
• 30801902111426: Maximal Barrier Drape
• 30801902111402: Arrow-Howes(TM) Quad-Lumen Central Venous Catheterization Set with Blue FlexTip(R) ARROWg+ard Bl
• 30801902111365: Arrowg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheter
• 30801902111334: Pressure Injectable ARROWg+ard Blue Plus(R) Multi-Lumen Central Venous Catheterization Kit
• 30801902111327: Arterial Catheterization Kit
• 30801902111310: Radial Artery Catheterization Kit
• 30801902111303: Arterial Catheterization Kit
• 30801902109591: Pressure Injectable ARROWg+ard Blue Plus(R) Multi-Lumen Central Venous Catheterization Kit
• 30801902109584: Pressure Injectable ARROWg+ard Blue PLUS(R) Multi-Lumen Central Venous Catheterization Kit
• 30801902109577: Pressure Injectable ARROWg+ard Blue PLUS(R) Quad-Lumen Central Venous Catheterization Kit
• 10801902109559: NextStep(R) Antegrade Hemodialysis Catheterization Set Long-Term Access. Catheter Length, Tip to
• 30801902109546: Edge(R) Hemodialysis Catheterization Set Long-Term Access Catheter Length, Cuff to Tip: 31 cm
• 30801902109539: Spring Wire Guide Kit
• 30801902109522: Arterial Line Kit
• 30801902109515: Arterial Catheterization Kit
• 10801902109504: 15 Fr. x 19 cm NextStep(R) Antegrade Hemodialysis Catheterization Set, Long-Term Access Catheter
• 30801902109485: Pressure Injectable ARROWg+ard Blue Plus(R) Multi-Lumen Central Venous Catheterization Kit
• 30801902109478: Arterial Line Kit with Sharps Safety Features
• 30801902109461: ARROWg+ard Blue(R) PSI Kit for use with 7.5 - 8 Fr. Catheters
• 30801902109454: Pressure Injectable ARROWg+ard Blue PLUS(R) Multi-Lumen Central Venous Catheterization Kit
• 30801902109447: Pressure Injectable ARROWg+ard Blue PLUS(R) Two-Lumen Central Venous Catheterization Kit
• 30801902109430: Pressure Injectable ARROWg+ard Blue PLUS(R) Multi-Lumen Central Venous Catheterization Kit
• 30801902109423: ARROWg+ard Blue(R) Percutaneous Sheath Introducer Kit for use with 7.5 - 8 Fr. Catheter
• 30801902109416: Pressure Injectable ARROWg+ard Blue PLUS(R) Multi-Lumen Central Venous Catheterization Kit
• 30801902109409: Pressure Injectable ARROWg+ard Blue PLUS(R) Two-Lumen Central Venous Catheterization Kit
• 30801902109218: Percutaneous Sheath Introducer Kit for use with 7.5 - 8 Fr. Catheters
• 30801902108464: Central Venous Catheterization Set with Blue FlexTip(R) Catheter
• 30801902108419: Central Venous Catheterization Set with Blue FlexTip(R) Catheter
• 30801902108396: Central Venous Catheterization Set with Blue FlexTip(R) Catheter
• 30801902108358: Central Venous Catheterization Set with Blue FlexTip(R) Catheter
• 30801902108327: Central Venous Catheterization Set with Blue FlexTip(R) Catheter
• 30801902106668: Pressure Injectable ARROWg+ard Blue PLUS(R) Multi-Lumen Central Venous Catheterization Kit
• 30801902105456: Two-Lumen Central Venous Catheterization Set with Blue FlexTip(R) Catheter
• 30801902105449: Two-Lumen Central Venous Catheterization Set with Blue FlexTip(R) Catheter
• 30801902105401: Two-Lumen Central Venous Catheterization Set with Blue FlexTip(R) Catheter
• 30801902105333: Multi-Lumen Central Venous Catheterization Set with Blue FlexTip(R) Catheter