Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008513424

FEI Number

3008513424

Entity Name

PACKROOM LLC

City/State/Country

Mc Donough, GA, US

Establishment Address

1281 Highway 155 South, Mc Donough, GA 30253, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Pack Room LLC (Owner Number: 10030702)

Owner / Operator Contact Address

1281 Highway 155 South, Suite 100, McDonough, GA 30253, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Packroom LLC Packroom LLC Packroom LLC Packroom LLC Packroom LLC Packroom LLC

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PWM	Admission Kit (Patient Utensil)	General Hospital	Class 1	880.6730	2019-01-31
LRS	I.V. Start Kit	General Hospital	Class 2	880.5200	2019-01-31
OEQ	Angiography/Angioplasty Kit	Cardiovascular	Class 2	870.1650	2010-07-15
MLS	Labor And Delivery Kit	Obstetrics/Gynecology	Class 2	884.4530	2010-07-15
OHM	Cesarean Section Tray	Obstetrics/Gynecology	Class 2	884.1720	2010-07-15
OES	Cardiac Catheterization Kit	Cardiovascular	Class 2	870.1200	2010-07-15

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Pack Room 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
K936120	Cush Medical Products	LABOR AND DELIVERY TRAY	1994-03-30

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0026-2020	Merit Medical Systems, Inc.	2	Custom Procedure Kit, Custom Kit, REF/Product Code: K12T-03688, single use, RX Only, Sterile EO, LATEX FREE, UDI: (01)00884450389409
Z-0015-2009	Medline Industries Inc	2	Medline Latex Free C-Section CDS-LF and C-Section Supplemental CDS-LF; a single patient prescription procedure pack and disposables, including a Gerber Nuk Pacifier; Made in USA by Medline Industries, Inc., Mundelein, IL 60060
Z-0016-2009	Medline Industries Inc	2	Medline Latex Free Vaginal Delivery CDS-LF; a single patient prescription procedure pack and disposables, including a Gerber Nuk Pacifier; Made in USA by Medline Industries, Inc., Mundelein, IL 60060
Z-0017-2009	Medline Industries Inc	2	Medline Latex Free Labor Kit & Postpartum CDS-LF; a single patient prescription procedure pack and disposables, including a Gerber Nuk Pacifier; Made in USA by Medline Industries, Inc., Mundelein, IL 60060
Z-0018-2009	Medline Industries Inc	2	Medline Latex Free Labor & Delivery CDS-LF; a single patient prescription procedure pack and disposables, including a Gerber Nuk Pacifier; Made in USA by Medline Industries, Inc., Mundelein, IL 60060

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008513424. Last updated year: 2026. Please use registration number 3008513424 when referencing this establishment in official correspondence.