FDA.reportPublic FDA data

CORFLO cuBBy LPGD

Primary DI
10815149022410
Brand
CORFLO cuBBy LPGD
Company
CORPAK MEDSYSTEMS, INC.
Model
55-1245
Catalog number
55-1245
Device description
Low profile gastrostomy device kit with ENFit Connectors
Published
2016-06-24
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
10815149022410PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1081514902241010815149022410

GMDN Terms

TermDefinition
Gastrostomy buttonA sterile, short, hollow tube that is inserted into the stomach percutaneously to permit long-term enteral feeding. The tube does not permit reflux and its external end is flush with abdominal skin. This is a single-use device.

Device Sizes

TypeValueUnit
Catheter Gauge12French

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00No

Sterilization Methods

Method
Ethylene Oxide

Contacts

PhoneEmail
+1(847)403-3400questions@corpak.com

Regulatory Flags

DUNS number
147530323
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
true
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
false
Sterilization required before use
true

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20815149021168CORGRIP Tube Retention System25-01225-0122016-08-04
20815149021731CORFLO Y Extension Set40-100740-10072016-07-28
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20815149025272Mapcath stylet60-201860-20182016-08-04
10815149025442CORGRIP Tube Retention System25-01425-0142017-02-27
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10815149025466CORGRIP Tube Retention System25-01825-0182017-02-27
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