FDA.reportPublic FDA data

n-Able Cath™

Primary DI
00851847007024
Brand
n-Able Cath™
Company
ADAPTA MEDICAL INC
Model
7025-2020
Catalog number
7025-2020
Device description
n-Able Cath Hydro-Straight, Sterile, Single-Use 14 French Intermittent Urinary Catheter.
Published
2016-12-28
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
GBMCatheter, Urethral

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GBMCatheter, UrethralGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851847007017PackageGS130In Commercial Distribution
00851847007024PackageGS112In Commercial Distribution
00851847007000PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851847007017008518470070178518470070170851847007017
00851847007024008518470070248518470070240851847007024
00851847007000008518470070008518470070000851847007000

GMDN Terms#

Term, Definition table
TermDefinition
Single-administration urethral drainage catheterA sterile, flexible tube intended to be inserted one-time through the urethra to the urinary bladder, by the patient/user or a healthcare provider, to provide urine drainage, typically for an individual who is physiologically incapable of voiding. It is typically made of polyvinyl chloride (PVC), and may be coated with a lubricating substance (e.g., acquires a smooth and mucous surface when brought in contact with water). The distal end can have various tip designs [e.g., open-ended, rounded with a side hole(s)], and the proximal end typically connects to a urine collection container. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge14French

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
855-329-8355brent.janaky@adaptamedical.com

Regulatory Flags#

DUNS number
836441613
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
00851847007000n-Able Cath™7025-20207025-20202016-12-28
00851847007031mPower Cath™7020-14687020-14682016-12-27
00851847007055PerfIC Cath™7020-15717020-15712016-12-28

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