Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007594734

FEI Number

3007594734

Entity Name

CellEra, LLC

City/State/Country

Monroe, OH, US

Establishment Address

1045 Reed Road, Unit C, Monroe, OH 45050, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

CellEra, LLC (Owner Number: 10029252)

Owner / Operator Contact Address

1045 Reed Road, Unit C, Monroe, OH 45050, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Vitale Collagen Dressings Vitale Silicone Super Absorbent Dressings Vitale Hydroconductive Dressings Vitale Cover Dressing Vitale STRONG Calcium Alginate Dressings Vitale Hydrogel Dressing Vitale STRONG Silver Calcium Alginate Dressing Glucertain Safety Lancets Vitale Wound Wash Jet System Vitale Collagen Dressings Vitale RTD Wound Dressing Glucertain Blood Glucose Test Strips Vitale Adhesive Foam Dressing Vitale Composite Dressing Vitale Non-Adhesive Foam Dressing Vitale Silicone Foam Dressing Vitale Foam Heel Dressing Vitale Sacral Silicone Foam Dressing Vitale Hydrocolloid Dressing Vitale Petrolatum Dressings Vitale Xeroform Dressings Vitale Non-Adherent Oil Emulsion Dressings Vitale Composite Post-Op Dressing

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2021-10-28
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2009-04-23
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2009-04-22
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2016-12-04
FMK	Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2012-01-06
FQH	Lavage, Jet	General Hospital	Class 2	880.5475	2023-08-31
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2025-12-04
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2025-06-10
LFR	Glucose Dehydrogenase, Glucose	Clinical Chemistry	Class 2	862.1345	2017-06-03
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2017-06-03
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2009-04-23

Official Correspondent

Ken Heyl

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

CellEra, 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
K112888	Kensey Nash Corporation	MESO WOUND MATRIX	2012-02-10
K040211	Collagen Matrix, Inc.	MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING	2004-02-27
K150256	Argentum Medical	SILVERLON BURN CONTACT DRESSINGS	2015-04-30
K130132	Medipurpose Pte. , Ltd.	BABYLANCE HEEL INCISION DEVICE	2013-02-11
K213616	Becton, Dickinson and Company	BD Surgiphor Antimicrobial Irrigation System	2022-03-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-06	B. Braun Medical, Inc.	U	D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage.
Z-0038-2025	3M Company Health Care Business 3m Center	U	3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R
Z-0044-2008	Becton Dickinson & Company	2	Microtainer Safety Flow Lancets; Green Sterile, Use Once and Discard; 1.4 mm Blade Length; 1.0mm Blade Width; Becton Dickinson Vacutainer Systems; Becton Dickinson & Company; Franklin Lakes, NJ 07417
Z-0004-2009	Lifescan Inc	2	One Touch Ultra Test Strips, part number 020-994-02, manufactured by LifeScan Inc, Milpitas, CA, 25 count. Intended to be used for quantitative measurement of glucose in fresh capillary whole blood. Intended for use outside the body (in vitro diagnostic use) by people with diabetes at home and healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. Intended for use on the finger, arm, or palm.
Z-0042-06	Abbott Laboratories Medisense Products	2	FreeStyle FLASH Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007594734. Last updated year: 2026. Please use registration number 3007594734 when referencing this establishment in official correspondence.