FDA.report

NeoConnect Enteral Extension Set

Primary DI
20817584011995
Brand
NeoConnect Enteral Extension Set
Company
NEOMED, INC.
Model
EXT-48BNC
Catalog number
EXT-48BNC
Device description
48" Large Bore Enteral Extension Set with ENFit Connector, Orange
Published
2016-09-19
Public version status
Update
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

Contact Domains

Product Codes

CodeName
KNTTubes, Gastrointestinal (And Accessories)

Product Code Classifications

CodeDeviceSpecialtyClass
KNTTubes, Gastrointestinal (And Accessories)Gastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10817584011998PackageGS150In Commercial Distribution
20817584011995PackageGS18In Commercial Distribution
00817584011991PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1081758401199810817584011998
2081758401199520817584011995
00817584011991008175840119918175840119910817584011991

GMDN Terms

TermDefinition
Nasoenteral tubeA sterile, thin, flexible, hollow cylinder designed to access the small intestines (duodenum or jejunum) through the nose and nasopharynx for examination (e.g., of intestinal contents), treatment (e.g., decompression, short-term feeding), or other purposes. It is a single- or dual-lumen, rubber or plastic tube (nasoduodenal or nasojejunal tube) that is smaller and longer than a nasogastric tube and may have a small weight or magnet at the distal tip to facilitate placement. It is frequently used for very ill or comatose patients. Some types are used to remove air and liquids from the stomach by connection to intermittent suction units and/or for enteral feeding. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
886-876-2225info@neomedinc.com

Regulatory Flags

DUNS number
799772079
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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