PRISMAFLO® II S PF2300NA

GUDID 04260114149897

Blood warmer

Stihler Electronic GmbH

Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer

• Primary Device ID: 04260114149897
• NIH Device Record Key: 9b0f8ab2-71b6-46af-9ebd-ce5f150a1a15
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PRISMAFLO® II S
• Version Model Number: PF2300NA
• Catalog Number: PF2300NA
• Company DUNS: 317742377
• Company Name: Stihler Electronic GmbH
• 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: false
• Serial Number: true
• Manufacturing Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260114149897 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082758

FDA Product Code

• KOC: ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS

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: 2016-08-31

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• 04260114140252 - ASTOPAD®: 2020-10-16 COV155-NA
• 04260114140269 - ASTOPAD®: 2020-10-16 COV180-NA
• 04260114140030 - ASTOPAD®: 2020-10-15 DUO310-NA
• 04260114140375 - ASTOTHERM® PLUS: 2018-07-06 Blood and infusion warmer