Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007225047

FEI Number

3007225047

Entity Name

HEMOSTASIS, LLC

City/State/Country

Saint Paul, MN, US

Establishment Address

5000 Township Pkwy, Saint Paul, MN 55110, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Hemostasis, LLC (Owner Number: 10023101)

Owner / Operator Contact Address

5000 Township Parkway, Saint Paul, MN 55110, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

NexFoam Plus Topical Hemostat Sponge NexStat Plus Topical Hemostat Powder PosiSepX Hemostat Dressing/Intranasal Splint PosiSep C Hemostat Dressing/Intranasal Splint PosiSep Hemostat Dressing /Intranasl Splint PosiSep C2 Hemostat Dressing/Intranasal Splint PosiSep X2 Hemostat Dressing/Intranasal Splint PosiSep X BioNocc NexStat Topical Hemostat Powder NexFoam Topical Hemostat Sponge BleedArrest ER Topical Hemostat GI Tank CO2 Flow Controller GI House CO2 Flow Controller PosiSep® X BAM PosiSep D2 Vectra F Vectra G Vensure Balloon Dilation System Vensure ET Balloon Dilation Vensure Nav Balloon Dilation System Vensure Light Balloon Dilation System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QSY	Hemostatic Wound Dressing Without Thrombin Or Other Biologics	Unknown	Class U	N/A	2012-11-19
LYA	Splint, Intranasal Septal	Ear, Nose, Throat	Class 1	874.4780	2012-11-19
NHB	Polymer, Ear, Nose And Throat, Synthetic, Absorbable	Ear, Nose, Throat	Class 2	874.3620	2012-11-19
EMX	Balloon, Epistaxis	Ear, Nose, Throat	Class 1	874.4100	2013-04-11
LYA	Splint, Intranasal Septal	Ear, Nose, Throat	Class 1	874.4780	2013-04-11
NHB	Polymer, Ear, Nose And Throat, Synthetic, Absorbable	Ear, Nose, Throat	Class 2	874.3620	2010-12-13
LYA	Splint, Intranasal Septal	Ear, Nose, Throat	Class 1	874.4780	2010-12-13
QSY	Hemostatic Wound Dressing Without Thrombin Or Other Biologics	Unknown	Class U	N/A	2010-12-13
BYM	Tube, Thorpe, Uncompensated	Anesthesiology	Class 1	868.2320	2024-08-01
EMX	Balloon, Epistaxis	Ear, Nose, Throat	Class 1	874.4100	2024-08-23
LYA	Splint, Intranasal Septal	Ear, Nose, Throat	Class 1	874.4780	2024-08-23
KCO	Nasal Spray, Ent Delivery	Ear, Nose, Throat	Class 1	874.5220	2018-05-25
LRC	Instrument, Ent Manual Surgical	Ear, Nose, Throat	Class 1	874.4420	2024-01-18
PNZ	Eustachian Tube Balloon Dilation Device	Ear, Nose, Throat	Class 2	874.4180	2024-01-18

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Hemostasis, LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K220566	Koag, LLC	Vascette HP (hemostatic pad)	2022-07-29
K080818	Hem Con Medical Technologies, Inc.	HEMCON BANDAGE, HEMCON BANDAGE OTC, HEMCON CHITOFLEX-SURGICAL DRESSING	2008-05-15
K893123	Les Laboratorires Brothier, S.A.	ADHESIVE BANDAGES & PADS FOR MINOR CUTS/SCRAPES	1990-02-13
K143462	Benq Materials Corporation	AnsCare ChitoClot Gauze (prescription use), AnsCare ChitoClot Gauze (over-the-counter use)	2015-05-08
K040208	Tz Medical, Inc.	NEPTUNE PAD, NEPTUNE DISC, NEPTUNE COMFORT-BAND, COMFORT-BAND	2004-05-11

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007225047. Last updated year: 2026. Please use registration number 3007225047 when referencing this establishment in official correspondence.