FDA.report

Septal-H

Primary DI
10709078013147
Brand
Septal-H
Company
WESTMED, INC.
Model
CP-5510
Device description
Septal-H Pediatric 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

Related Records

Product Codes

CodeName
FMPProtector, Skin Pressure
JAYSupport, Breathing Tube

Product Code Classifications

CodeDeviceSpecialtyClass
FMPProtector, Skin PressureGeneral Hospital1
JAYSupport, Breathing TubeAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10709078013147PackageGS180In Commercial Distribution
00709078013140PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1070907801314710709078013147
00709078013140007090780131407090780131400709078013140

GMDN Terms

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

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

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