Dale Airway Holder 260

GUDID 00817612021121

The Dale Airway Holder Short-Term Securement is intended for short-term airway securement of endotracheal tubes or laryngeal mask airways in critical settings, such as the operating room and prehospital or emergency medical services (EMS) environments. It is designed to secure the breathing tube and prevent inadvertent extubation.

Dale Medical Products, Inc.

Endotracheal tube holder
Primary Device ID00817612021121
NIH Device Record Key4b2fb7be-2f1a-4d84-a925-7d05b491f6c4
Commercial Distribution StatusIn Commercial Distribution
Brand NameDale Airway Holder
Version Model Number260
Catalog Number260
Company DUNS001061233
Company NameDale Medical Products, Inc.
Device Count50
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Countertrue

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Cool dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Cool dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Cool dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Cool dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Cool dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Cool dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Cool dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Cool dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Cool dry place

Device Identifiers

Device Issuing AgencyDevice ID
GS100817612021121 [Primary]
GS100817612021138 [Unit of Use]

FDA Product Code

CBHDevice, Fixation, Tracheal Tube

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-03-19
Device Publish Date2026-03-11

Devices Manufactured by Dale Medical Products, Inc.

00817612021121 - Dale Airway Holder2026-03-19The Dale Airway Holder Short-Term Securement is intended for short-term airway securement of endotracheal tubes or laryngeal mask airways in critical settings, such as the operating room and prehospital or emergency medical services (EMS) environments. It is designed to secure the breathing tube and prevent inadvertent extubation.
00817612021121 - Dale Airway Holder2026-03-19 The Dale Airway Holder Short-Term Securement is intended for short-term airway securement of endotracheal tubes or laryngeal mas
00817612021114 - Dale IV Line Manager2025-08-19 The Dale IV Line Manager is a foam device used to separate and organize up to 6 IV Lines
00817612021053 - Dale Post Surgical Compression Bra2025-04-08 Dale Post Surgical Compression Bra, Medium, fits B-D, 34"-36", 1 per box.
00817612021060 - Dale Post Surgical Compression Bra2025-04-08 Dale Post Surgical Compression Bra, Large, fits B-D, 36"-38", 1 per box.
00817612021077 - Dale Post Surgical Compression Bra2025-04-08 Dale Post Surgical Compression Bra, X-Large, fits B-D, 38"-44", 1 per box.
00817612021084 - Dale Post Surgical Compression Bra2025-04-08 Dale Post Surgical Compression Bra, XX-Large, fits C-E, 46"-54", 1 per box.
00817612021091 - Dale Post Surgical Compression Bra2025-04-08 Dale Post Surgical Compression Bra, XXX-Large, fits E-I, 54"-60", 1 per box.
00817612020971 - Dale Nasogastric Tube Holder, One Leg2024-04-30 Dale Nasogastric Tube Holder, Ultragrip, One Leg
© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.