FDA.report

PUGGLE™ G-Tube

Primary DI
30704411007283
Brand
PUGGLE™ G-Tube
Company
AMSINO INTERNATIONAL, INC.
Model
1
Catalog number
PLG16-10
Device description
PUGGLE™ G-Tube 16 Fr. 10 mL GASTROSTOMY TUBE WITH Y-PORTS
Published
2018-05-10
Public version status
Update
Distribution status
Not 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
KNTTubes, Gastrointestinal (And Accessories)

Product Code Classifications

CodeDeviceSpecialtyClass
KNTTubes, Gastrointestinal (And Accessories)Gastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
30704411007283PackageGS11Not in Commercial Distribution
40704411007280PackageGS120Not in Commercial Distribution
00704411007282PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
3070441100728330704411007283
4070441100728040704411007280
00704411007282007044110072827044110072820704411007282

GMDN Terms

TermDefinition
Enteral feeding kit, adult/paediatric, sterileA collection of 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
825673239
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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