Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3026197444

FEI Number

3026197444

Entity Name

INVENIO ALTERNATE CARE SOLUTIONS, LLC

City/State/Country

Peachtree Corners, GA, US

Establishment Address

3025 Northwoods Pkwy, Peachtree Corners, GA 30071, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Invenio Alternate Care Solutions, LLC (Owner Number: 10087239)

Owner / Operator Contact Address

3025 Northwoods Pkwy, Peachtree Corners, GA 30071, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Invenio

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NXA	Tracheotomy Care Kit	Anesthesiology	Class 2	868.5800	2024-08-12
OHM	Cesarean Section Tray	Obstetrics/Gynecology	Class 2	884.1720	2023-08-18
OJK	Eye Tray	Ophthalmic	Class 2	886.4790	2023-07-10
PYB	Minor Surgical Procedures Tray	General, Plastic Surgery	Class 1	878.4800	2025-01-29
KDC	Instrument, Surgical, Disposable	General, Plastic Surgery	Class 1	878.4800	2023-02-16
OJU	Skin Prep Tray	General, Plastic Surgery	Class 1	878.4800	2024-08-12
PWL	Oral Surgery Tray	Dental	Class 1	872.4565	2023-07-11
FTN	Plastic Surgery And Accessories Kit	General, Plastic Surgery	Class 1	878.3925	2023-02-05
OEZ	Cardiovascular Procedure Kit	Cardiovascular	Class 2	870.1200	2023-08-09
OXQ	Dressing Change Tray	General Hospital	Class 1	880.5075	2023-08-31

Official Correspondent

Carol Chang

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Invenio Alternate Care Solutions, 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
K831798	I M, Inc.	DISPOSABLE SCALPELS	1983-07-19

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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
Z-0019-2009	Medline Industries Inc	2	Medline Latex Free Mom/Baby Admit Kit - 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 3026197444. Last updated year: 2026. Please use registration number 3026197444 when referencing this establishment in official correspondence.