FDA.reportPublic FDA data

"Trach Tube Holder - Adult (19"" length)"

Primary DI
00616784462035
Brand
"Trach Tube Holder - Adult (19"" length)"
Company
Dynarex Corporation
Model
4620
Published
2019-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Single use
true

Product Codes#

Code, Name table
CodeName
CBHDevice, Fixation, Tracheal Tube

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CBHDevice, Fixation, Tracheal TubeAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00616784462035PrimaryGS10
00616784462011Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784462035006167844620356167844620350616784462035
00616784462011006167844620116167844620110616784462011

GMDN Terms#

Term, Definition table
TermDefinition
Tracheostomy tube neck holder, reusableA noninvasive device designed to be fastened around the neck of a patient to secure a tracheostomy device (tube, button) in situ. It is typically in the form of a dedicated strap/collar intended to connect to the tracheostomy device, which is not included. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008124539
Device count
50
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840117346307Vital Signs Stand, Compatible with item 10843108562026-06-08
00840117349544Drape Sheets, Tissue / Poly 2-ply, Black, 40" x 90" (101.6 cm x 228.6 cm)8150BLK2026-06-08
00840117349568Pillow Cases, Tissue / Poly 2-ply, Black, 21" x 30" (53.3 cm x 76.2 cm)8161BLK2026-06-08
00840117327610Titan-700 Bariatric Rollator102172023-12-28
00840117325968Platform Attachment102122023-03-24
00840117326026Dynarex Bari + Max Bariatric Platform Attachment102132023-03-24
00616784020419Vivid-Flex, Adjustable Height Rollator102042019-10-07
00616784021515Compact Steerable Knee Walker, With Basket, Steel102152019-10-08
00616784021614Steerable Knee Walker with Basket102162019-10-08
00616784020815DynaGo Duo Transport Rollator With 7.5" Casters and Plastic Footrest102082019-11-13
00840117325913Bari + Max Bariatric HD Steel Walker, Weight Capacity 700 lb.101692023-01-09
00840117336483Steel Button Folding Walker with 5 Wheels, Adults101702024-06-17
00616784020013DynaGo Zoom - Aluminum Rollator with 3" Wheels102002019-10-07
00616784020112Vivid-Quad, Rollator, With 6" Caster , Blue10201BL2019-10-07
00616784020211Vivid-Terrain, Rollator with 7.5" Caster102022019-10-07
00616784020310Titan-500 Bariatric Rollator102032019-10-07
00616784020129Vivid-Quad, Rollator, With 6" Caster, Red10201RD2019-11-07
00616784020136Vivid-Quad, Rollator, With 6" Caster, Black10201BK2019-11-07
00616784020143Vivid-Quad, Rollator, With 6" Caster, Pink10201PK2019-11-07
00616784016016DMECare Solutions Two Button Folding Walker, Adult (32"-39")101602019-10-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810003756015KENOREXKENTRON HEALTHCARE, INC.CBH2026-06-01
08904428744947OSSEOUS- NeckFit Tube HolderEON MEDITECH PRIVATE LIMITEDCBH2026-03-13
00612479280571McKessonMCKESSON MEDICAL-SURGICAL INC.CBH2026-01-26
00612479280601McKessonMCKESSON MEDICAL-SURGICAL INC.CBH2026-01-26
00612479280632McKessonMCKESSON MEDICAL-SURGICAL INC.CBH2026-01-26
00612479280663McKessonMCKESSON MEDICAL-SURGICAL INC.CBH2026-01-26
10192253044591ArgyleCardinal Health 200, LLCCBH2025-08-26
00848530105853Tracheostomy and Suction AccessorySUNSET HEALTHCARE SOLUTIONS, INC.CBH2025-06-03
10889483605141AirLife™AIRLIFECBH2025-03-18
10889483605134AirLife™AIRLIFECBH2025-03-13
00610075095834AnchorFast SlimFitHOLLISTER INCORPORATEDCBH2024-11-05
00610075095766AnchorFastHOLLISTER INCORPORATEDCBH2024-10-03
00610075095780AnchorFast GuardHOLLISTER INCORPORATEDCBH2024-09-03
00610075095810AnchorFast Guard SelectHOLLISTER INCORPORATEDCBH2024-09-03
10197344103607MEDLINEMEDLINE INDUSTRIES, INC.CBH2024-08-01
10197344103614MEDLINEMEDLINE INDUSTRIES, INC.CBH2024-08-01
10197344103621MEDLINEMEDLINE INDUSTRIES, INC.CBH2024-08-01
10197344103638MEDLINEMEDLINE INDUSTRIES, INC.CBH2024-08-01
10197344103645MEDLINEMEDLINE INDUSTRIES, INC.CBH2024-08-01
10197344103652MEDLINEMEDLINE INDUSTRIES, INC.CBH2024-08-01
10618125191625PoseyTIDI PRODUCTS, LLCCBH2024-05-03
10618125191670PoseyTIDI PRODUCTS, LLCCBH2024-05-03
00848530103514One Piece Tracheostomy Tie Adult 2.5cm x 43cm (17in)SUNSET HEALTHCARE SOLUTIONS, INC.CBH2024-03-20
00848530103521One Piece Tracheostomy Tie Pediatric 2.5cm x 30cm (11.5in)SUNSET HEALTHCARE SOLUTIONS, INC.CBH2024-03-20
00848530103538Two Piece Tracheostomy Tie Adult 2.5cm x 51cm (20in)SUNSET HEALTHCARE SOLUTIONS, INC.CBH2024-03-20
00848530103545Two Piece Tracheostomy Tie Pediatric 2cm x 25.5cm (10in)SUNSET HEALTHCARE SOLUTIONS, INC.CBH2024-03-20
00848530103552Two Piece Tracheostomy Tie Pediatric 2cm x 35.5cm (14in)SUNSET HEALTHCARE SOLUTIONS, INC.CBH2024-03-20
00848530103569Two Piece Tracheostomy Tie Pediatric 2cm x 45.5cm (18in)SUNSET HEALTHCARE SOLUTIONS, INC.CBH2024-03-20
10840330703410ProCureTwin Med, LLCCBH2024-02-23
10840330703908ProCureTwin Med, LLCCBH2024-02-23