FDA.reportPublic FDA data

HCS

Primary DI
00849027004529
Brand
HCS
Company
DYAD MEDICAL SOURCING, LLC
Model
HCS09001
Device description
1-Piece Tracheostomy Tube Holder
Published
2019-12-31
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
10849027004526PackageGS140Not in Commercial Distribution
30849027004520PackageGS110Not in Commercial Distribution
00849027004529PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084902700452610849027004526
3084902700452030849027004520
00849027004529008490270045298490270045290849027004529

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.

Regulatory Flags#

DUNS number
078572603
Device count
1
Premarket exempt
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00849027000149HCSHCS50062017-01-17
00849027000156HCSHCS50072017-01-17
00849027002587HCSHCS5006C2017-01-17
00849027001757HCSHCS11012019-12-31
00849027001764HCSHCS1101C2019-12-31
00849027001771HCSHCS11032019-12-31
00849027001788HCSHCS1103C2019-12-31
00849027001795HCSHCS11042019-12-31
00849027001801HCSHCS11052019-12-31
00849027001818HCSHCS11062019-12-31
00849027002846HCSHCS11022019-12-31
00849027005182HCSHCS11202021-01-31
00849027005199HCSHCS1120C2021-01-31
00849027005205HCSHCS11212021-01-31
00849027005212HCSHCS11222021-01-31
00849027005229HCSHCS1122C2021-01-31
00849027005236HCSHCS11232021-01-31
00849027005243HCSHCS11252021-01-31
00849027001740HCSHCS11002019-12-31
50849027001417HCSHCS3003XL2019-12-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719874951078Create BiotechCREATE BIOTECH CO., LTD.CBH2026-07-21
04719874958282Create BiotechCREATE BIOTECH CO., LTD.CBH2026-07-21
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
00860009651630KC Airway Tape - Long-termKelCor, LLCCBH2026-01-22
10192253044591ArgyleCardinal Health 200, LLCCBH2025-08-26
00848530105853Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.CBH2025-06-03
00848530105839Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.CBH2025-06-03
00848530105846Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.CBH2025-06-03
00848530105860Tracheostomy 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