Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1066733

FEI Number

3002910717

Entity Name

CHARTER MEDICAL, LLC

City/State/Country

Winston Salem, NC, US

Establishment Address

3948-A WEST POINT BLVD., Winston Salem, NC 27103, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

CHARTER MEDICAL, LLC. (Owner Number: 2246665)

Owner / Operator Contact Address

195 O'Neill Drive, Quakertown, PA 18951, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K000685

PMA Number

N/A

All Registered Proprietary Names

Cell Freeze Cryogenic Storage Container Tru-Flo Neo-40 Syringe Set Blood Transfer Set Advect Fluid Transfer Set Blood Transfer Bag Neonatal Syringe Set

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LPZ	Container, Frozen Donor Tissue Storage	Unknown	Class U	N/A	2011-05-27
JQC	Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use	Clinical Chemistry	Class 1	862.2050	2014-12-10
CAK	Microfilter, Blood Transfusion	General Hospital	Class 2	880.5440	2008-02-15
KSB	Set, Transfer (Blood/Plasma)	Hematology	Class 2	864.9875	2007-11-16
KSB	Set, Transfer (Blood/Plasma)	Hematology	Class 2	864.9875	2018-04-04
KSR	Container, Empty, For Collection & Processing Of Blood & Blood Components	Hematology	Class 2	864.9100	2007-12-20
BRZ	Set, Blood Transfusion	General Hospital	Class 2	880.5440	2013-12-27
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2007-11-16
BRZ	Set, Blood Transfusion	General Hospital	Class 2	880.5440	2007-11-16

Official Correspondent

Kitu Patel

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

CHARTER MEDICAL, 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
K873873	Travenol Laboratories, S.A.	RESUBMITTED MICRON TRANSFUSION FILTER	1987-10-22
K880350	Honway International Co.	YUE/FA DISPOSABLE SYRINGE	1988-02-16
K003571	Terumo Medical Corp.	SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE	2001-02-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes
Z-0004-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes
Z-0005-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 29G X 1/2 '' insulin syringes
Z-0005-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case
Z-0006-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case

Similar Registrations

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1058584	Sterigenics US LLC	Charlotte, NC, US
3005290010	Miltenyi Biotec B. V. & Co. KG	Bergisch Gladbach North Rhine-Westphalia, DE
3008264130	Miltenyi Biotec B. V. & Co. KG Branch Teterow	Teterow Mecklenburg-Western Pomerania, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1066733. Last updated year: 2026. Please use registration number 1066733 when referencing this establishment in official correspondence.