FDA.reportPublic FDA data

Enteral Delivery Pump Bag Set

Primary DI
00616784427539
Brand
Enteral Delivery Pump Bag Set
Company
DYNAREX CORPORATION
Model
4275
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

Product Codes#

Code, Name table
CodeName
KNTTubes, Gastrointestinal (And Accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNTTubes, Gastrointestinal (And Accessories)Gastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00616784427539PrimaryGS10
00616784427515Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784427539006167844275396167844275390616784427539
00616784427515006167844275156167844275150616784427515

GMDN Terms#

Term, Definition table
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 table
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00616784709734Blood Pressure Cuff Kits, Sphygmomanometer, 3-Cuffs, Child, Adult, Large Adult70972017-11-21
00616784710327Disposable ECG Snap Electrodes, With Pre-Gelled AG/AGCI Sensor71032016-09-24
00616784710518Sphygmomanometer71052016-09-24
00616784710617Sphygmomanometer71062016-09-24
00616784711027Single Head Stethoscope, Single Head71102021-04-22
00616784711126Stethoscope Dual Head71112021-04-22
00616784711225PA SensiLance Pressure Activated Safety Lancets, Sterile71122021-05-21
00616784711423PA [SensiLance Pressure Activated Safety Lancets,Sterile71142021-05-21
00616784709833Blood Pressure Cuff Kits, Sphygmomanometer, 5-Cuffs, Infant, Child, Adult, Large70982017-11-21
00616784709529Digital Blood Pressure Monitor70952021-01-19
00616784709628Digital Blood Monitors70962021-01-19
00616784709925Blood Pressure Kit,Sphymomanometer with Dual Head Stethoscope70992016-09-24
00616784710020Blood Pressure Kit Sphygmomanometer with Stethoscope71002016-09-24
00616784710228Disposable ECG Snap Electrodes, With Pre-Gelled AG/AGCI Sensor71022016-09-24
00840117344761Resp-O2 Closed Suction Endotracheal Catheter, 8 FR (2.6 mm)310612026-05-25
00840117344778Resp-O2 Closed Suction Endotracheal Catheter, 8 FR (2.6 mm)310622026-05-25
00840117346215Resp-O2 Closed Suction Endotracheal Catheter, 10 FR (3.3 mm)310632026-05-25
00840117349711IV Extension Sets Needle-Free Luer Lock Connector For Injection, Non-Toxic, 17"70612016-09-24
00840117349742IV Extension Sets Needle-Free Luer Lock Connector, Non-Toxic, 8" (20.3 cm)70622016-09-24
00616784706313IV Extension Sets Needle-Free Luer Lock Connector for Injection Non-Toxic70632024-03-25

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