FDA.report

Resp-O2 Comfort-Foam Trach Tube Holder

Primary DI
00840117319271
Brand
Resp-O2 Comfort-Foam Trach Tube Holder
Company
DYNAREX CORPORATION
Model
35029
Device description
Resp-O2 Comfort-Foam Trach Tube Holder, Large, 2 PC, Adult, Maximum Neck Size 19.5"/50 cm
Published
2022-05-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
CBHDevice, Fixation, Tracheal Tube

Product Code Classifications

CodeDeviceSpecialtyClass
CBHDevice, Fixation, Tracheal TubeAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840117319110PackageGS110In Commercial Distribution
00840117319196PackageGS15In Commercial Distribution
00840117319271PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840117319110008401173191108401173191100840117319110
00840117319196008401173191968401173191960840117319196
00840117319271008401173192718401173192710840117319271

GMDN Terms

TermDefinition
Tracheostomy tube neck holder, single-useA non-sterile, 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 single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
008124539
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00810180843331Durma+ DynaRule Disposable Paper Rulers30062026-03-24
00810180845106Cotton Tipped Wood Applicators, Sterile43042022-04-22
00810180845113Cotton Tipped Wood Applicators, Sterile43052022-04-22
00810180840712CurPro Dermal Curettes,2 mm 41552024-12-16
00840117347892Medi-Cut Safety Scalpel41652022-04-17
00810180844901Disposable Prep Razors42512020-11-02
00810180844918Medicine Cups 1oz 42522024-10-28
00810180844925LabChoice Specimen Container, Screw-On, Leak-Resistant Lid, Tamper-Ever Seal 42542021-06-21
00810180844703Bandage Shears 7.5" Orange4183-BX2020-11-08
00810180844710Bandage Shears 7.5" Purple4184-BX2020-11-08
00810180844840Emesis Basin42242022-05-02
00810180844857Sitz Bath42282021-09-01
00810180844864Urinal- Male42292021-09-01
00810180844871Bed Pans42302021-04-22
00810180844888Bed Pans42312021-04-22
00810180844895Nuns Cap Specimen Collector42322021-04-22
00840117331822DynaSafety Heavy Duty Woven Fabric Knuckle Bandages, 1 1/2" x 3"3765BULK2024-03-08
00840117331853DynaSafety Heavy Duty Woven Fabric Bandages, Large Patch, 2" x 3"3766BULK2024-03-08
00840117331907DynaSafety Heavy Duty Woven Fabric Bandages, Sterile, 7/8" x 3"3767BULK2024-03-08
00840117350045Pill Crusher Pouch42102021-09-01

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
08904428798438OSSEOUS- NeckFit Tube HolderEON MEDITECH PRIVATE LIMITEDCBH2026-03-13
00817612021121Dale Airway HolderDale Medical Products, Inc.CBH2026-03-11
00860013007652HORSESHOE ET Tube Securement Device + StrapSurgicure Technologies, Inc.CBH2026-03-04
00860013007676HORSESHOE Head StrapSurgicure Technologies, Inc.CBH2026-03-04
00850027043791Precision MedicalPrecision Medical, Inc.CBH2026-02-25
00850027043807Precision MedicalPrecision Medical, Inc.CBH2026-02-25
00612479280588McKessonMCKESSON MEDICAL-SURGICAL INC.CBH2026-01-26
00612479280618McKessonMCKESSON MEDICAL-SURGICAL INC.CBH2026-01-26
00612479280649McKessonMCKESSON MEDICAL-SURGICAL INC.CBH2026-01-26
00612479280670McKessonMCKESSON MEDICAL-SURGICAL INC.CBH2026-01-26
00860009651630KC Airway Tape - Long-termKelCor, LLCCBH2026-01-22
06979032640048GOBENHUZHOU JUNDA INDUSTRY CO., LTD.CBH2025-08-26
50192253044599ArgyleCardinal Health 200, LLCCBH2025-08-26
16974600043563KONLIDASuzhou Konlida Medical Supplies Co., Ltd.CBH2025-07-28
16974600043570KONLIDASuzhou Konlida Medical Supplies Co., Ltd.CBH2025-07-28
16974600043587KONLIDASuzhou Konlida Medical Supplies Co., Ltd.CBH2025-07-28
16974600043594KONLIDASuzhou Konlida Medical Supplies Co., Ltd.CBH2025-07-28
16974600043600KONLIDASuzhou Konlida Medical Supplies Co., Ltd.CBH2025-07-28
16974600043617KONLIDASuzhou Konlida Medical Supplies Co., Ltd.CBH2025-07-25
00860013007638HORSESHOE ET Tube Securement DeviceSurgicure Technologies, Inc.CBH2025-07-23
06978579510012ToTXinCareTongxin Home Care Industry (Shenzhen) Co., LimitedCBH2025-06-04
06978579510029ToTXinCareTongxin Home Care Industry (Shenzhen) Co., LimitedCBH2025-06-04
06978579510036ToTXinCareTongxin Home Care Industry (Shenzhen) Co., LimitedCBH2025-06-04
06978579510043ToTXinCareTongxin Home Care Industry (Shenzhen) Co., LimitedCBH2025-06-04
00848530105839Tracheostomy and Suction AccessorySUNSET HEALTHCARE SOLUTIONS, INC.CBH2025-06-03
00848530105846Tracheostomy and Suction AccessorySUNSET HEALTHCARE SOLUTIONS, INC.CBH2025-06-03
10848530105850Tracheostomy and Suction AccessorySUNSET HEALTHCARE SOLUTIONS, INC.CBH2025-06-03
00848530105860Tracheostomy and Suction AccessorySUNSET HEALTHCARE SOLUTIONS, INC.CBH2025-06-03
00860013007614HORSESHOE ET Tube Securement DeviceSurgicure Technologies, Inc.CBH2025-06-03
30889483605145AirLife™Sunmed Group Holdings, LLCCBH2025-03-18