Pentair DPB3022PES002YN

GUDID B4623452800003

PENTAIR FILTRATION SOLUTIONS, LLC

Cardiopulmonary bypass system filter, priming solution

• Primary Device ID: B4623452800003
• NIH Device Record Key: a47db591-cb64-487a-8279-2e17594ad5c7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pentair
• Version Model Number: 345280000
• Catalog Number: DPB3022PES002YN
• Company DUNS: 057656759
• Company Name: PENTAIR FILTRATION SOLUTIONS, LLC
• Device Count: 75
• 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: true
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-759-6693
• Email: efcustomerservice@pentair.com
• Phone: 1-800-759-6693
• Email: efcustomerservice@pentair.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B4623452800000 [Unit of Use]
HIBCC	B4623452800003 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K990276

FDA Product Code

• KRJ: Filter, Prebypass, Cardiopulmonary Bypass

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: 2017-12-31

On-Brand Devices [Pentair]

• B462SF14385: SF1438
• B462P0750X0303: P0750X030
• B462IP3: IP
• B462INVFILTER5: INVFILTER
• B462IBFP5: IBFP
• B462HLTH5203: HLTH520
• B462FLT1801Q5: FLT1801Q
• B462FBF3818MPT3: FBF3818MPT
• B462FBF316143: FBF31614
• B462FBF14385: FBF1438
• B462DPC2023S500C5: DPC2023S500C
• B462DPB3032PES002YV5: DPB3032PES002YV
• B462DPB3032PES002YN3: DPB3032PES002YN
• B462DPB3022PES002YN3: DPB3022PES002YN
• B462DPB30223: DPB3022
• B462DFC06DV5: DFC06DV
• B462DFC0699M03YTM5: DFC0699M03YTM
• B462DFC0622M03YSC5: DFC0622M03YSC
• B462DDF4799M03YPM3: DDF4799M03YPM
• B462DDF47995: DDF4799
• B462DDF4711M03YFJ3: DDF4711M03YFJ
• B462DDF47115: DDF4711
• B462DDF4700M02YHM3: DDF4700M02YHM
• B462DDF4700M02YHF3: DDF4700M02YHF
• B462DBH32K04TA5: DBH32K04TA
• B462DBF32K04FJ5: DBF32K04FJ
• B462DBF32K04FD5: DBF32K04FD
• B462DBF32K04BU5: DBF32K04BU
• B462DBF325: DBF32
• B462DBF23UPB5: DBF23UPB
• B462DBF23UHF5: DBF23UHF
• B462DBF23U5: DBF23U
• B462BMP1733: BMP173
• B46287200065: 8720006
• B46286727H015: 86727H01
• B4627700015: 770001
• B462762575: 76257
• B46275037175: 7503717
• B4627010543855: 701054385
• B4627010310863: 701031086
• B4627010310843: 701031084
• B4627010210403: 701021040
• B4627010210393: 701021039
• B4626411305: 641130
• B4626411085: 641108
• B46261265: 6126
• B46261255: 6125
• B4625056535: 505653
• B46250135001005: 5013500100
• B4624724230000013: 472423000001