The Insides Neo

Primary DI
09421905447195
Brand
The Insides Neo
Company
THE INSIDES COMPANY LIMITED
Model
PS028
Device description
The Insides Neo x1 Pouch
Published
2023-05-26
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
EXBCollector, Ostomy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EXBCollector, OstomyGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09421905447201PackageGS13Not in Commercial Distribution
09421905447218PackageGS110Not in Commercial Distribution
09421905447195PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09421905447201094219054472019421905447201
09421905447218094219054472189421905447218
09421905447195094219054471959421905447195

GMDN Terms#

Term, Definition table
TermDefinition
ENFit/ENFit linear connectorA small, non-powered, noninvasive, tubular, two-way/linear connector with an ENFit connection (designed according to ISO 80369-3 for enteral applications) at both ends intended to connect two enteral devices (e.g., enteral syringe, feeding tube, administration set) with each other; it does not have a Luer connection(s) (neither lock nor slip), and does not incorporate a filter, valve, clamp nor tubing. This is a single-use device.

Regulatory Flags#

DUNS number
594825946
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09421905447225The Insides NeoPS0312025-10-16
09421905447218The Insides NeoPS0282023-05-26

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Primary DI, Brand, Company table
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