FDA.report

Monoject

Primary DI
20192253007722
Brand
Monoject
Company
Cardinal Health 200, LLC
Model
460SE
Catalog number
460SE
Device description
60 mL Enteral Syringe For use with ENFit Connection System
Published
2026-02-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
PNREnteral Syringes with enteral specific connectors

Product Code Classifications

CodeDeviceSpecialtyClass
PNREnteral Syringes With Enteral Specific ConnectorsGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20192253007722PackageGS130In Commercial Distribution
50192253007723PackageGS14In Commercial Distribution
10192253007725PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2019225300772220192253007722
5019225300772350192253007723
1019225300772510192253007725

GMDN Terms

TermDefinition
ENFit oral/enteral syringe, single-useA manual device intended to be used for the administration of oral medication or delivery of enteral nutrition by connection to an enteral administration device. It consists of a calibrated hollow barrel (cylinder) and a moveable plunger intended to be operated by a healthcare provider or parent device. The tip is designed to mate only with enteral administration devices (i.e., ENFit) and is incompatible with Luer connectors; the device may be colour-coded to distinguish it from syringes designed to mate with infusion/injection devices. It may include appropriate accessories (e.g., cap, bottle adaptor). This is a single-use device.

Device Sizes

TypeValueUnit
Total Volume60Milliliter

Sterilization Methods

Method

Regulatory Flags

DUNS number
961027315
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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