PPS PI

GUDID 13661234011213

Pressure Injectable Safety Huber Needle

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	13661234011213
NIH Device Record Key	c43726e9-1779-4475-b625-9f8c4a7fe4f7
Commercial Distribution Status	In Commercial Distribution
Brand Name	PPS PI
Version Model Number	U201914
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	03661234011216 [Primary]
GS1	13661234011213 [Package] Contains: 03661234011216 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

Trademark Results [PPS PI]

Mark Image Registration \| Serial	Company Trademark Application Date
PPS PI 85447525 4756207 Live/Registered	Perouse Medical 2011-10-14