MiniONE Balloon Button SM1-5-2023

GUDID 00842071143077

20FR x 2.3 cm MiniONE Balloon Button Single Pack - Low Profile Feeding Device, MDR

APPLIED MEDICAL TECHNOLOGY, INC.

Gastrostomy button
Primary Device ID00842071143077
NIH Device Record Key460cb5e2-d40b-40a5-8e68-7135e62eb531
Commercial Distribution StatusIn Commercial Distribution
Brand NameMiniONE Balloon Button
Version Model NumberSM1-5-2023
Catalog NumberSM1-5-2023
Company DUNS038101861
Company NameAPPLIED MEDICAL TECHNOLOGY, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(440) 717-4000
Emailcs@appliedmedical.net
Phone(440) 717-4000
Emailcs@appliedmedical.net
Phone(440) 717-4000
Emailcs@appliedmedical.net
Phone(440) 717-4000
Emailcs@appliedmedical.net
Phone(440) 717-4000
Emailcs@appliedmedical.net
Phone(440) 717-4000
Emailcs@appliedmedical.net
Phone(440) 717-4000
Emailcs@appliedmedical.net
Phone(440) 717-4000
Emailcs@appliedmedical.net
Phone(440) 717-4000
Emailcs@appliedmedical.net
Phone(440) 717-4000
Emailcs@appliedmedical.net
Phone(440) 717-4000
Emailcs@appliedmedical.net
Phone(440) 717-4000
Emailcs@appliedmedical.net
Phone(440) 717-4000
Emailcs@appliedmedical.net
Phone(440) 717-4000
Emailcs@appliedmedical.net
Phone(440) 717-4000
Emailcs@appliedmedical.net
Phone(440) 717-4000
Emailcs@appliedmedical.net

Device Dimensions

Length2.3 Centimeter
Catheter Gauge20 French
Length2.3 Centimeter
Catheter Gauge20 French
Length2.3 Centimeter
Catheter Gauge20 French
Length2.3 Centimeter
Catheter Gauge20 French
Length2.3 Centimeter
Catheter Gauge20 French
Length2.3 Centimeter
Catheter Gauge20 French
Length2.3 Centimeter
Catheter Gauge20 French
Length2.3 Centimeter
Catheter Gauge20 French
Length2.3 Centimeter
Catheter Gauge20 French
Length2.3 Centimeter
Catheter Gauge20 French
Length2.3 Centimeter
Catheter Gauge20 French
Length2.3 Centimeter
Catheter Gauge20 French
Length2.3 Centimeter
Catheter Gauge20 French
Length2.3 Centimeter
Catheter Gauge20 French
Length2.3 Centimeter
Catheter Gauge20 French
Length2.3 Centimeter
Catheter Gauge20 French

Device Identifiers

Device Issuing AgencyDevice ID
GS100842071143077 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KNTTubes, Gastrointestinal (And Accessories)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-11-04
Device Publish Date2024-10-25

On-Brand Devices [MiniONE Balloon Button]

0084207114574310FR x 9.5 cm MiniONE Balloon Button Single Pack - Low Profile Feeding Device, MDR
0084207114573610FR x 9.0 cm MiniONE Balloon Button Single Pack - Low Profile Feeding Device, MDR
0084207114572910FR x 8.5 cm MiniONE Balloon Button Single Pack - Low Profile Feeding Device, MDR
0084207114571210FR x 8.0 cm MiniONE Balloon Button Single Pack - Low Profile Feeding Device, MDR
0084207114570510FR x 7.5 cm MiniONE Balloon Button Single Pack - Low Profile Feeding Device, MDR
0084207114569910FR x 7.0 cm MiniONE Balloon Button Single Pack - Low Profile Feeding Device, MDR
0084207114568210FR x 6.5 cm MiniONE Balloon Button Single Pack - Low Profile Feeding Device, MDR
0084207114567510FR x 6.0 cm MiniONE Balloon Button Single Pack - Low Profile Feeding Device, MDR
0084207114566810FR x 5.5 cm MiniONE Balloon Button Single Pack - Low Profile Feeding Device, MDR
0084207114565110FR x 5.0 cm MiniONE Balloon Button Single Pack - Low Profile Feeding Device, MDR
0084207114564410FR x 4.4 cm MiniONE Balloon Button Single Pack - Low Profile Feeding Device, MDR
0084207114563710FR x 4.0 cm MiniONE Balloon Button Single Pack - Low Profile Feeding Device, MDR
0084207114562010FR x 3.5 cm MiniONE Balloon Button Single Pack - Low Profile Feeding Device, MDR
0084207114561310FR x 3.0 cm MiniONE Balloon Button Single Pack - Low Profile Feeding Device, MDR
0084207114560610FR x 2.7 cm MiniONE Balloon Button Single Pack - Low Profile Feeding Device, MDR
0084207114559010FR x 2.5 cm MiniONE Balloon Button Single Pack - Low Profile Feeding Device, MDR
0084207114558310FR x 2.3 cm MiniONE Balloon Button Single Pack - Low Profile Feeding Device, MDR
0084207114557610FR x 2.0 cm MiniONE Balloon Button Single Pack - Low Profile Feeding Device, MDR
0084207114556910FR x 1.7 cm MiniONE Balloon Button Single Pack - Low Profile Feeding Device, MDR
0084207114555210FR x 1.5 cm MiniONE Balloon Button Single Pack - Low Profile Feeding Device, MDR
0084207114554510FR x 1.2 cm MiniONE Balloon Button Single Pack - Low Profile Feeding Device, MDR
0084207114553810FR x 10.0 cm MiniONE Balloon Button Single Pack - Low Profile Feeding Device, MDR
0084207114552110FR x 1.0 cm MiniONE Balloon Button Single Pack - Low Profile Feeding Device, MDR
0084207114551410FR x 0.8 cm MiniONE Balloon Button Single Pack - Low Profile Feeding Device, MDR
0084207114550710FR x 0.5 cm MiniONE Balloon Button Single Pack - Low Profile Feeding Device, MDR
0084207114549110FR x 9.0cm MiniONE Balloon Button - Low Profile Feeding Device (ENFit), MDR
0084207114548410FR x 9.0cm MiniONE Balloon Button - Low Profile Feeding Device, MDR
0084207114547710FR x 8.5cm MiniONE Balloon Button - Low Profile Feeding Device (ENFit), MDR
0084207114546010FR x 8.5cm MiniONE Balloon Button - Low Profile Feeding Device, MDR
0084207114545310FR x 8.0cm MiniONE Balloon Button - Low Profile Feeding Device (ENFit), MDR
0084207114544610FR x 8.0cm MiniONE Balloon Button - Low Profile Feeding Device, MDR
0084207114543910FR x 7.5cm MiniONE Balloon Button - Low Profile Feeding Device (ENFit), MDR
0084207114542210FR x 7.5cm MiniONE Balloon Button - Low Profile Feeding Device, MDR
0084207114541510FR x 7.0cm MiniONE Balloon Button - Low Profile Feeding Device (ENFit), MDR
0084207114540810FR x 7.0cm MiniONE Balloon Button - Low Profile Feeding Device, MDR
0084207114539210FR x 6.5cm MiniONE Balloon Button - Low Profile Feeding Device (ENFit), MDR
0084207114538510FR x 6.5cm MiniONE Balloon Button - Low Profile Feeding Device, MDR
0084207114537810FR x 6.0cm MiniONE Balloon Button - Low Profile Feeding Device (ENFit), MDR
0084207114536110FR x 6.0cm MiniONE Balloon Button - Low Profile Feeding Device, MDR
0084207114535410FR x 5.5cm MiniONE Balloon Button - Low Profile Feeding Device (ENFit), MDR
0084207114534710FR x 5.5cm MiniONE Balloon Button - Low Profile Feeding Device, MDR
0084207114533010FR x 5.0cm MiniONE Balloon Button - Low Profile Feeding Device (ENFit), MDR
0084207114532310FR x 5.0cm MiniONE Balloon Button - Low Profile Feeding Device, MDR
0084207114531610FR x 4.4cm MiniONE Balloon Button - Low Profile Feeding Device (ENFit), MDR
0084207114530910FR x 4.4cm MiniONE Balloon Button - Low Profile Feeding Device, MDR
0084207114529310FR x 4.0cm MiniONE Balloon Button - Low Profile Feeding Device (ENFit), MDR
0084207114528610FR x 4.0cm MiniONE Balloon Button - Low Profile Feeding Device, MDR
0084207114527910FR x 3.5cm MiniONE Balloon Button - Low Profile Feeding Device (ENFit), MDR
0084207114526210FR x 3.5cm MiniONE Balloon Button - Low Profile Feeding Device, MDR
0084207114525510FR x 3.0cm MiniONE Balloon Button - Low Profile Feeding Device (ENFit), MDR
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