FDA.reportPublic FDA data

Navina™ Classic system regular refill

Primary DI
07392532198472
Brand
Navina™ Classic system regular refill
Company
Dentsply Ih AB
Model
69006
Catalog number
6900640
Device description
Navina Classic Transanal irrigation. Refill. 1 Navina Classic control unit, 1 Water container, 1 Tube set, 2 Rectal catheters regular. Non Sterile Device. Rx Only.
Published
2017-11-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
KNTTUBES, GASTROINTESTINAL (AND ACCESSORIES)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNTTubes, Gastrointestinal (And Accessories)Gastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170487000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170487000Navina Classic SystemDentsply Sirona2017-09-11KNT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07392532198472PackageGS13In Commercial Distribution
07392532198465PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07392532198472073925321984727392532198472
07392532198465073925321984657392532198465

GMDN Terms#

Term, Definition table
TermDefinition
Manual rectal irrigation systemA portable assembly of manually-operated devices designed to be used by or on a patient to irrigate the rectum with water, typically to provoke the defecation reflex for the evacuation of the bowels to treat/prevent constipation and reduce the risk of faecal incontinence. It typically consists of a control unit that regulates the air/water balance and includes a manually-operated hand pump to propel the water, a container for the water (e.g., a plastic bag), and a rectal catheter to channel the water. It is intended for use in the home and healthcare facility. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)456-3742info-lofric-usa@wellspect.com

Regulatory Flags#

DUNS number
354059073
Device count
1
DM exempt
false
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
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07392532208492LoFric® Elle™418122541812052022-04-01
07392532208522LoFric® Elle™418142541814052022-04-01
07392532274305LoFric® Elle™418105041810502022-04-01
07392532274336LoFric® Elle™418125041812502022-04-01
07392532274367LoFric® Elle™418145041814502022-04-01
07392532247255LoFric® Hydro-Kit™42008420084032020-12-04
07392532247279LoFric® Hydro-Kit™42010420104032020-12-04
07392532247316LoFric® Hydro-Kit™42012420124032020-12-04
07392532247347LoFric® Hydro-Kit™42014420144032020-12-04
07392532247361LoFric® Hydro-Kit™42016420164032020-12-04
07392532247408LoFric® Hydro-Kit™42018420184032020-12-04
07392532247439LoFric® Hydro-Kit™42108421084032020-12-04
07392532247453LoFric® Hydro-Kit™42110421104032020-12-04
07392532247491LoFric® Hydro-Kit™42308423084032020-12-04
07392532247521LoFric® Hydro-Kit™42310423104032020-12-04
07392532247576LoFric® Hydro-Kit™42312423124032020-12-04
07392532247606LoFric® Hydro-Kit™42314423144032020-12-04
07392532247637LoFric® Hydro-Kit™42316423164032020-12-04

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