POLPERF SAFE

GUDID 13661234014085

PEROUSE MEDICAL

Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle

• Primary Device ID: 13661234014085
• NIH Device Record Key: 4437339e-d530-45f6-818d-36d55ba7afd6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: POLPERF SAFE
• Version Model Number: U102214
• Company DUNS: 267476323
• Company Name: PEROUSE MEDICAL
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	03661234014088 [Primary]
GS1	13661234014085 [Package]; Contains: 03661234014088; Package: [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063631

FDA Product Code

• FMI: Needle, hypodermic, single lumen

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-01-08
• Device Publish Date: 2016-09-16

Devices Manufactured by PEROUSE MEDICAL

• 33661234025207 - PEROUSE MEDICAL: 2024-04-17 NEEDLE GUIDE Ø1,2MM
• 43661234025198 - PEROUSE MEDICAL: 2024-04-03 NEEDLE GUIDE Ø1,0MM
• 43661234025235 - PEROUSE MEDICAL: 2024-04-03 NEEDLE GUIDE Ø0,9MM
• 33661234025184 - PEROUSE MEDICAL: 2024-03-28 NEEDLE GUIDE Ø0,9MM
• 43661234025228 - PEROUSE MEDICAL: 2024-03-28 NEEDLE GUIDE Ø1,8MM
• 33661234025245 - PEROUSE MEDICAL: 2024-03-28 NEEDLE GUIDE Ø1,0MM
• 33661234025252 - PEROUSE MEDICAL: 2024-03-22 NEEDLE GUIDE Ø1,2MM
• 33661234025269 - PEROUSE MEDICAL: 2024-03-22 NEEDLE GUIDE Ø2,25MM