FDA.reportPublic FDA data

TRACH-MATE HOLDER INFANT

Primary DI
00610570176823
Brand
TRACH-MATE HOLDER INFANT
Company
Bird & Cronin, LLC
Model
90008230
Published
2022-08-30
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

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
00610570176823PrimaryGS10
00610570166770Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00610570176823006105701768236105701768230610570176823
00610570166770006105701667706105701667700610570166770

GMDN Terms#

Term, Definition table
TermDefinition
Endotracheal tube holderA device designed to hold and stabilize an endotracheal (ET) tube when it has been intubated into a patient; it may also include a teeth protector to prevent damage to the teeth or tube during intubation. It typically consists of straps, pinch rings, cloth ties, or Velcro bands and provides the advantage of easy readjustment of the tube without retaping or the use of safety pins. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
045975349
Device count
48
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00610570191390B-Cool Chest & AB Binder Wrap081425212023-05-23
00610570191406B-Cool Chest & AB Binder Wrap081425222023-05-23
00610570191413B-Cool Chest & AB Binder Wrap081425242023-05-23
50610570191418B-Cool Chest & AB Binder Wrap081425232023-05-23
00610570191451B-Cool Super Sling Plus Universal (Complete Set)081482612023-02-20
00610570191581Short Anklizer Low Profile Walker XS081491372023-02-20
00610570191598Short Anklizer Low Profile Walker Small081491382023-02-20
00610570191604Short Anklizer Low Profile Walker Medium081491392023-02-20
00610570191611Short Anklizer Low Profile Walker Large081491402023-02-20
00610570191628Short Anklizer Low Profile Walker X-LG081491412023-02-20
00610570191444B-Cool Super Sling Universal (Sling Only)081482602023-02-16
00610570063277APNEA HEAD & CHIN STRAP081482232022-10-31
00610570088065CONTOURED CERV COLLAR 2" UNIV081400392022-10-31
00610570115655PRODY BULB HOLDER081482202022-10-31
00610570166756UNIVERSAL ARM SLING081400152022-08-01
00610570174607ENVELOPE STYLE ARM SLING XS081400612022-08-02
00610570174614ENVELOPE STYLE ARM SLING SM081400622022-08-02
00610570174621ENVELOPE STYLE ARM SLING MD081400632022-08-02
00610570174638ENVELOPE STYLE ARM SLING LG081400642022-08-02
00610570174645ENVELOPE STYLE ARM SLING XL081400652022-08-02

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