FDA.reportPublic FDA data

PUGGLE™ G-Tube

Primary DI
30704411007344
Brand
PUGGLE™ G-Tube
Company
AMSINO INTERNATIONAL, INC.
Model
1
Catalog number
PLG24-20
Device description
PUGGLE™ G-Tube 24 Fr. 20 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

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
30704411007344PackageGS11Not in Commercial Distribution
40704411007341PackageGS120Not in Commercial Distribution
00704411007343PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3070441100734430704411007344
4070441100734140704411007341
00704411007343007044110073437044110073430704411007343

GMDN Terms#

Term, Definition table
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 table
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
40704411021088AMSafe® I.V. Administration Set11010802B2025-12-29
40704411020241AMSure® 0.9% Sodium Chloride lrrigation USP 100 mL, Sterile1AS-62402025-12-05
40704411020258AMSure® Sterile Water for lrrigation USP 100 mL1AS-62502025-12-05
00704411020267AMSure® Sterile Water for lrrigation USP 250 mL1AS-62602025-12-05
40704411020272AMSure® 0.9% Sodium Chloride lrrigation USP 250 mL, Sterile1AS-62702025-12-05
40704411020500AMSure® 0.9% Sodium Chloride lrrigation USP 500 mL, Sterile1AS-63802025-12-05
40704411020517AMSure® Sterile Water for lrrigation USP 500 mL1AS-63902025-12-05
40704411020524AMSure® 0.9% Sodium Chloride lrrigation USP 1000 mL, Sterile1AS-64812025-12-05
40704411020531AMSure® Sterile Water for lrrigation USP 1000 mL1AS-64912025-12-05
40704411008829AMSure ® HG Hydrophilic Intermittent Urethral Catheter1HG9716102025-07-02
40704411008836AMSure ® HG Hydrophilic Intermittent Urethral Catheter1HG9716122025-07-02
40704411008843AMSure ® HG Hydrophilic Intermittent Urethral Catheter1HG9716142025-07-02
40704411008850AMSure ® HG Hydrophilic Intermittent Urethral Catheter1HG9716162025-07-02
10704411008866AMSure®HG Hydrophilic Intermittent Urethral Catheter1HG971610SS2025-07-02
40704411008874AMSure®HG Hydrophilic Intermittent Urethral Catheter1HG971612SS2025-07-02
40704411008881AMSure®HG Hydrophilic Intermittent Urethral Catheter1HG971614SS2025-07-02
40704411008898AMSure®HG Hydrophilic Intermittent Urethral Catheter1HG971616SS2025-07-02
40704411019542AMSure® Foley Catheter Tray1AS894142025-07-01
40704411019559AMSure® Foley Catheter Tray1AS894162025-07-01
40704411019566AMSure® Foley Catheter Tray1AS894182025-07-01

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