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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)

Page 1 of 3

Device	Model / Reference	Registries	Class	Status
Dale Nasal Dressing Holder	600	FDA UDI	Class I	Active
Dale Foley Catheter Holder	316	FDA UDI	Class I	Active
Dale Nasogastric Tube Holder	161	FDA UDI	Class I	Active
Dale Adhesive Base	273	FDA UDI	Class I	Active
Dale Catheter Securement Device	854	FDA UDI	Class I	Unknown
Dale ENFit ACE Connector	485	FDA UDI	Class II	Active
Dale Foley Catheter Holder	150	FDA UDI	Class I	Active
Dale Abdominal Binder	818	FDA UDI	Class I	Unknown
Dale Post Surgical Bra	705	FDA UDI	Class I	Unknown
Dale Catheter Securement Device	850	FDA UDI	Class I	Unknown
Dale Catheter Securement Device	853	FDA UDI	Class I	Unknown
Dale Adhesive Base	273	FDA UDI	Class I	Active
Dale Abdominal Binder	820	FDA UDI	Class I	Unknown
Dale Endotracheal Tube Holder	270	FDA UDI	Class I	Active
Dale General Purpose Securement Device	951	FDA UDI	Class I	Unknown
Dale Catheter Securement Device	851	FDA UDI	Class I	Unknown
Dale Post Surgical Bra	706	FDA UDI	Class I	Unknown
Dale Post Surgical Bra	703	FDA UDI	Class I	Unknown
Dale Endotracheal Tube Holder	270	FDA UDI	Class I	Active
Dale Bendable Armboard	650	FDA UDI	Class I	Active
Dale PediPrints	242	FDA UDI	Class I	Active
Dale Catheter Securement Device	852	FDA UDI	Class I	Unknown
Dale 200 One Piece Holder	200	FDA UDI	Class I	Unknown
Dale General Purpose Securement Device	952	FDA UDI	Class I	Unknown
Dale Abdominal Binder	411	FDA UDI	Class I	Unknown
Dale Endotracheal Tube Holder	280	FDA UDI	Class I	Active
Dale Catheter Securement Device	849	FDA UDI	Class I	Unknown
Dale Post Surgical Bra	704	FDA UDI	Class I	Unknown
Dale Bendable Armboard	653	FDA UDI	Class I	Active
Dale Nasogastric Tube Holder	160	FDA UDI	Class I	Active
Dale Catheter Securement Device	848	FDA UDI	Class I	Unknown
Dale Abdominal Binder	810	FDA UDI	Class I	Unknown
Dale Abdominal Binder	418	FDA UDI	Class I	Unknown
Dale Bendable Armboard	651	FDA UDI	Class I	Active
Dale Abdominal Binder	920	FDA UDI	Class I	Unknown
Dale Post Surgical Bra	702	FDA UDI	Class I	Unknown
Dale Bendable Armboard	652	FDA UDI	Class I	Active
Dale PediPrints	241	FDA UDI	Class I	Active
Dale Urodynamic Tube Holder	490	FDA UDI	Class I	Unknown
Dale Abdominal Binder	410	FDA UDI	Class I	Unknown
Dale ACE Connector	475	FDA UDI	Class II	Active
Dale Abdominal Binder	525	FDA UDI	Class I	Unknown
Dale IV Armor	675	FDA UDI	Class I	Active
Daily Cardiac Cooling Jacket	C1116, C1123, C1130	FDA UDI	Class II	Active
Dale Abdominal Binder	811	FDA UDI	Class I	Active
Dale Transducer Holder	620	FDA UDI	Class I	Active
Dale 240 Blue	240	FDA UDI	Class I	Active
Dale ENFit ACE Connector	485	FDA UDI	Class II	Active
Dale General Purpose Securement Device	950	FDA UDI	Class I	Unknown
Dale ACE Connector	475	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

MDSS GmbH DE

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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