PPS PI

GUDID 13661234011435

Pressure Injectable Safety Huber Needle

PEROUSE MEDICAL

Subcutaneous infusion/injection port needle

• Primary Device ID: 13661234011435
• NIH Device Record Key: e449c0c0-9450-464f-83d1-8a352b7dbedc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PPS PI
• Version Model Number: U212010
• 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	03661234011438 [Primary]
GS1	13661234011435 [Package]; Contains: 03661234011438; Package: [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120261

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 [PPS PI]

• 13661234011510: Pressure Injectable Safety Huber Needle
• 13661234011503: Pressure Injectable Safety Huber Needle
• 13661234011497: Pressure Injectable Safety Huber Needle
• 13661234011480: Pressure Injectable Safety Huber Needle
• 13661234011473: Pressure Injectable Safety Huber Needle
• 13661234011466: Pressure Injectable Safety Huber Needle
• 13661234011459: Pressure Injectable Safety Huber Needle
• 13661234011442: Pressure Injectable Safety Huber Needle
• 13661234011435: Pressure Injectable Safety Huber Needle
• 13661234011428: Pressure Injectable Safety Huber Needle
• 13661234011411: Pressure Injectable Safety Huber Needle
• 13661234011404: Pressure Injectable Safety Huber Needle
• 13661234011398: U211914
• 13661234011381: Pressure Injectable Safety Huber Needle
• 13661234011374: Pressure Injectable Safety Huber Needle
• 13661234011367: Pressure Injectable Safety Huber Needle
• 13661234011350: Pressure Injectable Safety Huber Needle
• 13661234011343: Pressure Injectable Safety Huber Needle
• 13661234011336: Pressure Injectable Safety Huber Needle
• 13661234011329: Pressure Injectable Safety Huber Needle
• 13661234011312: Pressure Injectable Safety Huber Needle
• 13661234011305: Pressure Injectable Safety Huber Needle
• 13661234011299: Pressure Injectable Safety Huber Needle
• 13661234011282: Pressure Injectable Safety Huber Needle
• 13661234011275: Pressure Injectable Safety Huber Needle
• 13661234011268: Pressure Injectable Safety Huber Needle
• 13661234011251: Pressure Injectable Safety Huber Needle
• 13661234011244: Pressure Injectable Safety Huber Needle
• 13661234011237: Pressure Injectable Safety Huber Needle
• 13661234011220: Pressure Injectable Safety Huber Needle
• 13661234011213: Pressure Injectable Safety Huber Needle
• 13661234011206: Pressure Injectable Safety Huber Needle
• 13661234011190: Pressure Injectable Safety Huber Needle
• 13661234011183: Pressure Injectable Safety Huber Needle
• 13661234011176: Pressure Injectable Safety Huber Needle
• 13661234011169: Pressure Injectable Safety Huber Needle