Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1066421

FEI Number

3003395204

Entity Name

BIOLIFE, LLC

City/State/Country

SARASOTA, FL, US

Establishment Address

8163 25th Ct E, SARASOTA, FL 34243, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

BIOLIFE, LLC (Owner Number: 9046506)

Owner / Operator Contact Address

8163 25th Court East, --, Sarasota, FL 34243, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K130324

PMA Number

N/A

All Registered Proprietary Names

WoundSeal + Applicator WoundSeal MD + Applicator WoundSeal Powder WoundSeal Rapid Response StatSeal Powder StatSeal Disc StatSeal Advanced Disc StatSeal Advanced Plus Disc StatSeal Advanced RAD Disc StatSeal Extra Small Disc StatSeal Medium Disc StatSeal Extra Large Disc StatSeal Large Disc

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	2007-11-13
QSY	Hemostatic Wound Dressing Without Thrombin Or Other Biologics	Unknown	Class U	N/A	2013-11-05

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

BIOLIFE, 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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1018233	C.R. BARD, INC.	COVINGTON, GA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1066421. Last updated year: 2026. Please use registration number 1066421 when referencing this establishment in official correspondence.