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Dale Medical Products, Inc.

United States·US-MF-000019061

Last updated September 17, 2026

About

Customer Survey We value your feedback and it helps us to continue to make Dale Always Better. Perspectives in Nursing Since 2001 Dale has been the proud

From the manufacturer's own website. Source

What Dale Medical Products, Inc. makes

The company manufactures reusable and single-use medical accessories for patient care, including endotracheal tube holders, tracheostomy tube neck holders, and reusable armboards. It also produces sterile enteral feeding kits for adults and children, noninvasive nasogastric tube holders, urinary catheter holders, and non-adhesive retention bandages. Electrode/transducer straps and adhesive bases for securing medical devices are part of its portfolio, alongside specialized connectors like the ENFit ACE for enteral feeding systems.

The portfolio includes devices classified as Class I and Class II under regulatory frameworks, with listings in the EU’s eudamed database, the FDA’s 510(k) premarket notification program, and the FDA’s Unique Device Identifier (UDI) system. The company is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: United States
Address: 40, Kenwood Circle, Franklin, United States
Website: www.dalemed.com
LinkedIn: linkedin.com/company/dalemedical
Facebook: facebook.com/DaleMedicalProducts
Email: [email protected]
Phone: 1.508.695.9316
PRRC Contact: Raymond Gruneberg
EUDAMED SRN: US-MF-000019061
FDA FEI Number: 1214422
DUNS Number: —

Catalogue (119)

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Device	Model / Reference	Registries	Class	Status
Dale 244 Blue	244	FDA UDI	Class I	Active
Dale Foley Catheter Holder	330	FDA UDI	Class I	Active
Dale Post-Surgical Bra, Medium	702	EUDAMEDFDA UDI	Class I	Active
Dale Scrape-n-Suction Tongue Cleaner	220	EUDAMEDFDA UDI	Class I	Active
Dale Post-Surgical Bra, XX-Large	705	EUDAMEDFDA UDI	Class I	Active
Dale 240 Blue	240	EUDAMEDFDA UDI	Class I	Active
Dale Post Surgical Compression Bra Size X-Large	714	EUDAMEDFDA UDI	Class I	Active
Dale Post Surgical Compression Bra Size XXX-Large	716	EUDAMEDFDA UDI	Class I	Active
Neonatal Ecg Electrode, M203ken	K092744	FDA 510(k)	Class II	Active
Wound Drainage Holder	K973183	FDA 510(k)	Class I	Active
Topical Cooling Pad, Model 7000	K905568	FDA 510(k)	Class II	Active
Myocardial Temperature Monitoring Probes, Cj-1000	K905652	FDA 510(k)	Class II	Active
Dale Ventilator Tubing Support For Trach. Vent.	K905231	FDA 510(k)	Class I	Active
Dale(r) Nasal Dressing Holder (product No. 600)	K914245	FDA 510(k)	Class I	Active
Dale Endotracheal Tube Holder	K832946	FDA 510(k)	Class I	Active
Dale Tracheostomy Tube Holder With Trach Mask Attachment Tabs	K951491	FDA 510(k)	Class I	Active
Cardiac Cooling Jacket, 8 Cm, Model Cj-120	K896974	FDA 510(k)	Class II	Active
Dale Head Band Anesthesia Circuit Tube Holder 1315	K860583	FDA 510(k)	Class I	Active
Nasogastric Tube Holder, Model 160	K994300	FDA 510(k)	Class II	Active
Dale I.v. Identifier; Product #1125	K894586	FDA 510(k)	Class I	Active
Cardiac Cooling Jacket, 12 Cm, Model Cj-520	K896972	FDA 510(k)	Class II	Active
Cardiac Cooling Jacket, 30% Reduced, Model Cj-220	K896975	FDA 510(k)	Class II	Active
Dale Venipuncture Tourniquet, Product No. 1335	K864897	FDA 510(k)	Class I	Active
Dale Gastrostomy Tube Holder	K961693	FDA 510(k)	Class II	Active
Fiberoptic Tympanic Thermometer, Model 6000	K914005	FDA 510(k)	Class II	Active
Cardiac Cooling Jacket, 8 Cm, Model Cj-420	K896971	FDA 510(k)	Class II	Active
Dale I.v. Connect. Lock & Stabilizer (stabilok)220	K873311	FDA 510(k)	Class I	Active
The Dale Ace Connector (access Controller For Enteral), Model H84104751	K082241	FDA 510(k)	Class II	Active
Comfort Stim	K001117	FDA 510(k)	Class II	Active
Circumaural Adhesive Replacement	K111555	FDA 510(k)	Class II	Active
Cardiac Cooling Jacket, 30% Enlarged, Model Cj-320	K896973	FDA 510(k)	Class II	Active
Dale Combo Tracheostomy Tube Holder	K812429	FDA 510(k)	Class I	Active
Dale Endotracheal Tube Holder 270/280	K964399	FDA 510(k)	Class I	Active
Hold-n-Place Bariatric Legband	330	EUDAMEDFDA UDI	Class I	Active
Dale IV Armor	675	EUDAMEDFDA UDI	Class I	Active
Dale NasoGastric Tube Holder	161	EUDAMEDFDA UDI	Class I	Active
Dale 260 Airway Holder	260	EUDAMED	Class I	Active
Dale Abdominal Binder	411	EUDAMEDFDA UDI	Class I	Active
Dale Abdominal Binder	418	EUDAMEDFDA UDI	Class I	Active
Dale Transducer Holder	620	EUDAMEDFDA UDI	Class I	Active
Dale Post Surgical Compression Bra SizeMedium	712	EUDAMEDFDA UDI	Class I	Active
Dale Medical	701	EUDAMEDFDA UDI	Class I	Active
Dale Post-Surgical Bra, X-Large	704	EUDAMEDFDA UDI	Class I	Active
Dale 244 Bariatric	244	EUDAMEDFDA UDI	Class I	Active
Dale Abdominal Binder	920	EUDAMEDFDA UDI	Class I	Active
Dale Bendable Armboard	652	EUDAMEDFDA UDI	Class I	Active
Dale Nasogastric Tube Holder	163	EUDAMEDFDA UDI	Class I	Active
Dale 242 PediPrints	242	EUDAMEDFDA UDI	Class I	Active
Dale Abdominal Binder	810	EUDAMEDFDA UDI	Class I	Active
Dale Post-Surgical Bra, Large	703	EUDAMEDFDA UDI	Class I	Active

Related Companies

Authorised Representatives

MDSS GmbH DE

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Authorities

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FDA Recalls (4)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Dale Medical Products, Inc. has four recall records listed in the FDA database, all initiated between September 27, 2007, and March 24, 2017, with each record marked as terminated. The reasons provided include issues with adhesive properties of ET Tube Holders, where the adhesive faceplate may fail to adhere to the patient’s face, and revised labeling instructions for a product, specifying that fastener hook tabs should not be trimmed to prevent disengagement at the trach plate.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Mar 24, 2017	Z-1927-2017	—	terminated	ET Tube Holders contain an adhesive faceplate that may lose its adhesive properties and will not adhere to the patient's face.
Mar 24, 2017	Z-1928-2017	—	terminated	ET Tube Holders contain an adhesive faceplate that may lose its adhesive properties and will not adhere to the patient's face.
Sep 27, 2007	Z-0447-2008	—	terminated	Revised Labeling : Instructions For use: "Do not trim fastener hook tabs. " Trimming can cause tabs to disengage at the trach plate
Sep 27, 2007	Z-0446-2008	—	terminated	Revised Labeling : Instructions For use: "Do not trim fastener hook tabs. " Trimming can cause tabs to disengage at the trach plate