FDA.reportPublic FDA data

n-Able Cath™

Primary DI
00851847007000
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
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.
Special Storage Condition, Specify00Keep dry.
Storage Environment Temperature40 Degrees Fahrenheit85 Degrees Fahrenheit

Contacts#

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

Regulatory Flags#

DUNS number
836441613
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851847007024n-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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