FDA.reportPublic FDA data

PreVent Endo Holder

Primary DI
10850014574632
Brand
PreVent Endo Holder
Company
PEPPER MEDICAL INC.
Model
790B
Catalog number
790B
Device description
Endo Trach Tube Holder with Bite Block
Published
2025-03-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Single use
true

Product Codes#

Code, Name table
CodeName
JAYSupport, Breathing Tube

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JAYSupport, Breathing TubeAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850014574611PackageGS112In Commercial Distribution
10850014574632PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850014574611008500145746118500145746110850014574611
1085001457463210850014574632

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.

Regulatory Flags#

DUNS number
622637098
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850014574208Foley Loc6506502020-04-17
00850014574185Foley Tie6066062020-04-17
00850014574192Tube Tie544554452020-04-17
10850014574014Pepper Medical Closed SuctionCS24-DS-14CS24-DS-142025-09-11
10850014574038Pepper Medical Closed SuctionCS24-T-14CS24-T-142025-09-11
10850014574052Pepper Medical Closed SuctionCS24-10-ETTCS24-10-ETT2025-09-11
00850014574659Pepper MedicalHME-712-Mini2025-11-07
00850014574406Trach Tie5025022020-04-17
00850014574413Trach Tie502P502P2020-04-17
00850014574154Trach Tie501W501W2020-04-17
00850014574215Trach Tie100110012020-04-17
10850014574878Pepper Medical Closed SuctionCS24-6CS24-62025-09-15
10850014574892Pepper Medical Closed SuctionCS24-8-ETTCS24-8-ETT2025-09-15
10850014574915Pepper Medical Closed SuctionCS24-T-12CS24-T-122025-09-15
10850014574922Pepper Medical Closed SuctionCS24-T-16CS24-T-162025-09-15
10850014574830Pepper Medical Closed SuctionCS24-12-ETTCS24-12-ETT2025-09-15
10850014574861Pepper Medical Closed SuctionCS24-6CS24-62025-09-15
10850014574885Pepper Medical Closed SuctionCS24-8-ETTCS24-8-ETT2025-09-15
10850014574908Pepper Medical Closed SuctionCS24-T-12CS24-T-122025-09-15
10850014575066Pepper Medical Closed SuctionCS24-T-16CS24-T-162025-09-15

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Primary DI, Brand, Company table
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10889483228692SavEar™ SUNMED, LLCJAY2025-12-15
10889483230244AirLife™SUNMED, LLCJAY2025-12-15
00653658009019Marpac IncMarpac, Inc.JAY2025-06-06
10850014574625PreVent Endo HolderPEPPER MEDICAL INC.JAY2025-03-26
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