FDA.reportPublic FDA data

Marpac Inc

Primary DI
10653658030836
Brand
Marpac Inc
Company
Marpac, Inc.
Model
308-3D
Catalog number
308-3D
Device description
Endotracheal tube holder adhesive precut tape strip, neonatal/pediatric, size 3, box contains 25ea
Published
2023-04-12
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

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
10653658030836PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1065365803083610653658030836

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

Contacts#

Phone, Email table
PhoneEmail
1-505-344-4740sales@marpacmedical.com

Regulatory Flags#

DUNS number
794035683
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00653658009019Marpac Inc901-SSDD/107901D2025-06-06
00858388004017BreatheWear Halo Chinstrap by Marpac8-H34078-H34072023-06-06
10653658009504Marpac Inc950D950D2023-04-13
10653658009511Marpac Inc951D951D2023-04-13
10653658030812Marpac Inc308-1D308-1D2023-04-12
10653658030829Marpac Inc308-2D308-2D2023-04-12
20653658003868Marpac Inc386B386B2023-04-12
20653658003899Marpac Inc389B389B2023-04-12
10653658022053Marpac Inc220SD220SD2023-04-10
00653658003017Marpac Inc3012023-04-06
00653658003024Marpac Inc3022023-04-06
00653658003048Marpac Inc3042023-04-06
00653658003055Marpac Inc3052023-04-06
00653658003062Marpac Inc3062023-04-06
00653658003208Marpac Inc3202023-04-06
00653658003215Marpac Inc3212023-04-06
00653658003406Marpac Inc3402023-04-06
00653658001020Marpac Inc1022023-04-03
00653658001051Marpac Inc1052023-04-03
00653658001068Marpac Inc1062023-04-03

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