POLYPERF SAFE

GUDID 13661234014078

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: 13661234014078
• NIH Device Record Key: 1adacefc-d16c-4aaa-8b28-e110e728fc3f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: POLYPERF SAFE
• Version Model Number: U102212
• 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	03661234014071 [Primary]
GS1	13661234014078 [Package]; Contains: 03661234014071; 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

On-Brand Devices [POLYPERF SAFE]

• 13661234014269: U112214
• 13661234014252: U112212
• 13661234014245: U112210
• 13661234014238: U112208
• 13661234014221: U112207
• 13661234014214: U112206
• 13661234014207: U112014
• 13661234014191: U112012
• 13661234014184: U112010
• 13661234014177: U112008
• 13661234014160: U112007
• 13661234014153: U112006
• 13661234014146: U111914
• 13661234014139: U111912
• 13661234014122: U111910
• 13661234014115: U111908
• 13661234014108: U111907
• 13661234014092: U111906
• 13661234014078: U102212
• 13661234014061: U102210
• 13661234014054: U102208
• 13661234014047: U102207
• 13661234014030: U102206
• 13661234014023: U102014
• 13661234014016: U102012
• 13661234014009: U102010
• 13661234013996: U102008
• 13661234013989: U102007
• 13661234013972: U102006
• 13661234013965: U101914
• 13661234013958: U101912
• 13661234013941: U101910
• 13661234013934: U101908
• 13661234013927: U101907
• 13661234013910: U101906