FDA.reportPublic FDA data

Septal-H

Primary DI
10709078013130
Brand
Septal-H
Company
WESTMED, INC.
Model
CP-5500
Device description
Septal-H Infant Size (1 Pack = 20 individual units
Published
2021-06-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
FMPProtector, Skin Pressure
JAYSupport, Breathing Tube

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMPProtector, Skin PressureGeneral Hospital1
JAYSupport, Breathing TubeAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10709078013130PackageGS180In Commercial Distribution
00709078013133PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1070907801313010709078013130
00709078013133007090780131337090780131330709078013133

GMDN Terms#

Term, Definition table
TermDefinition
Personal device holder, single-useA patient-worn, flexible device designed to hold a portable medical device (e.g., long-term recorder, portable oxygen equipment, urine collection bag, tracheostoma protector) during ambulation or sleep; it is neither designed to hold an invasive tube/catheter to the skin surface (i.e., not a catheter/tube holder), nor to house and protect a device from damage (i.e., not a rigid case/housing). It is typically designed as a bag, pouch, strap, belt, or clothing. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
092673953
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
true
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
00709078007781Composite Respiratory Kit07992019-10-18
00709078012693Septal-H Infant SizeCP-5500A2021-10-08
00709078012716Septal-H Pediatric SizeCP-5510A2021-10-08
00709078012990CapetteCP-42012021-06-25
00709078013003CapetteCP-42022021-06-25
00709078013010CapetteCP-42032021-06-25
00709078013027CapetteCP-44012021-06-25
00709078013034CapetteCP-44022021-06-25
00709078013041CapetteCP-44032021-06-25
00709078013058StrapetteCP-42042021-06-25
00709078013065StrapetteCP-42202021-06-25
00709078013072StrapetteCP-44042021-06-25
00709078013089StrapetteCP-44202021-06-25
00709078013096ChinstrapCP-51002021-06-25
00709078013102ChinstrapCP-52002021-06-25
00709078013119Septal-HCP-54002021-06-30
00709078013126Septal-HCP-54102021-06-30
00709078013133Septal-HCP-55002021-06-30
00709078013140Septal-HCP-55102021-06-30
00709078013157SavEarRT-61002021-06-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860010482674AcanthusAcanthus Medical Creations LLCFMP2026-05-27
15019517382488ICU Medical, Inc.ICU MEDICAL, INC.JAY2026-04-06
15019517382495ICU Medical, Inc.ICU MEDICAL, INC.JAY2026-04-06
15019517382501ICU Medical, Inc.ICU MEDICAL, INC.JAY2026-04-06
10889483228579Capette™SUNMED, LLCJAY2025-12-31
10889483225462Septal-H™SUNMED, LLCJAY2025-12-16
10850014574625PreVent Endo HolderPEPPER MEDICAL INC.JAY2025-03-26
10850014574632PreVent Endo HolderPEPPER MEDICAL INC.JAY2025-03-26
10603354600666TruVueEHOB INCFMP2025-03-20
10603354300696WAFFLEEHOB INCFMP2024-12-18
40080196150091MedlineMEDLINE INDUSTRIES, INC.JAY2024-03-27
07613327632873Sage TAP LCSAGE PRODUCTS, LLCFMP2024-03-26
G096R9292209LineRising Eagle Medical LLCFMP2024-01-30
10850014574700Endo TiePEPPER MEDICAL INC.JAY2023-10-25
10850014574717Trach TiePEPPER MEDICAL INC.JAY2023-10-25
10850014574724Trach TiePEPPER MEDICAL INC.JAY2023-10-25
20845854082536Paradigm RevolutionConmed CorporationFMP2023-06-13
20845854082901Paradigm RevolutionConmed CorporationFMP2023-06-13
20845854082918Paradigm RevolutionConmed CorporationFMP2023-06-13
G0648317270013971TurnAssist®POSITION HEALTH, LLCFMP2022-12-09
307073877890853M™ Reston™3M COMPANYFMP2022-12-08
10190676006516POSEYPOSEY PRODUCTS, LLCFMP2022-10-06
10190676006523POSEYPOSEY PRODUCTS, LLCFMP2022-10-06
15060797553242Light Cloud David Scott CompanyFMP2022-07-18
15060797551286Blue DiamondDavid Scott CompanyFMP2022-07-07
15060797551644Blue DiamondDavid Scott CompanyFMP2022-07-07
15060797551972Blue DiamondDavid Scott CompanyFMP2022-07-07
15060797552283Blue DiamondDavid Scott CompanyFMP2022-07-07
10850009091038Protecta-Gel®J.R.J. MEDICAL INNOVATIONS, LLCFMP2022-01-10
10850009091045Protecta-Gel®J.R.J. MEDICAL INNOVATIONS, LLCFMP2022-01-10