FDA.report

Enteral Delivery Gravity Bag Set

Primary DI
00616784428031
Brand
Enteral Delivery Gravity Bag Set
Company
DYNAREX CORPORATION
Model
4280
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
KNTTubes, Gastrointestinal (And Accessories)

Product Code Classifications

CodeDeviceSpecialtyClass
KNTTubes, Gastrointestinal (And Accessories)Gastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00616784428031PrimaryGS10
00616784428024Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784428031006167844280316167844280310616784428031
00616784428024006167844280246167844280240616784428024

GMDN Terms

TermDefinition
Enteral feeding kit, adult/paediatric, non-sterileA collection of non-sterile devices that includes tubing and other materials intended to administer nutrient liquids directly into the stomach, duodenum, or jejunum of an adult or paediatric (excludes infants) patient by means of gravity or an enteral pump. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
008124539
Device count
30
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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