FDA.reportPublic FDA data

ProCure

Primary DI
30840330703902
Brand
ProCure
Company
Twin Med, LLC
Model
1006875
Catalog number
1006875
Device description
Trach Tube Holder Reduces Skin Sensitivity Small -10ea/bx
Published
2024-02-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Contact Domains#

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
30840330703902PackageGS110In Commercial Distribution
10840330703908PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3084033070390230840330703902
1084033070390810840330703908

GMDN Terms#

Term, Definition table
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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length17Inch
Width1.5Inch

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
612-819-1635sanderson@twinmed.com

Regulatory Flags#

DUNS number
107071289
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
30840330705869ProCurePCHCB002PCHCB0022025-11-26
30840330705876ProCurePCHCB002LPCHCB002L2025-11-26
30840330705883ProCurePCHCB004PCHCB0042025-11-26
30840330705890ProCurePCHWCS183PCHWCS1832025-11-26
30840330705906ProCurePCHWCS1415PCHWCS14152025-11-26
30840330705913ProCurePCHWCS144PCHWCS1442025-11-26
30840330705920ProCurePCHWCS124PCHWCS1242025-11-26
30840330705937ProCurePCHWCS143PCHWCS1432025-11-26
30840330701731ProCurePCKDK20PCKDK202025-05-31
30840330701748ProCurePCKDC20PCKDC202025-05-31
30840330701755ProCurePCCIT10PCCIT102025-05-31
30840330701762ProCurePCCIT30PCCIT302025-05-31
30840330701779ProCurePCUCIT14PCUCIT142025-05-31
30840330701786ProCurePCUCIT14RPCUCIT14R2025-05-31
30840330701793ProCurePCDB20HPCDB20H2025-05-31
30840330701809ProCurePCDB20PCDB202025-05-31
30840330701557ProCurePCHTF22PCHTF222025-04-17
30840330705425ProCure100897010089702025-01-20
30840330701816ProCurePC700PC7002024-11-21
30840330701823ProCurePC710PC7102024-11-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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