FDA.report

Enteral Feeding Syringe

Primary DI
00616784426433
Brand
Enteral Feeding Syringe
Company
DYNAREX CORPORATION
Model
4264
Device description
Enteral Feeding Syringe, 60cc for Pole Bag, Non-Sterile
Published
2021-09-01
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
KYXDispenser, Liquid Medication

Product Code Classifications

CodeDeviceSpecialtyClass
KYXDispenser, Liquid MedicationGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00616784426433PackageGS130In Commercial Distribution
00616784426419PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784426433006167844264336167844264330616784426433
00616784426419006167844264196167844264190616784426419

GMDN Terms

TermDefinition
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 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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
008124539
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
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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