AMT MiniONE Extension Set E8-1224-ISOSAF, 8-1224-ISOSAF

GUDID 00842071132811

12" MiniONE Right Angle Feeding Set with ENFit® [ENFit®/Medication Port with Cap] (Pouched), MDR

APPLIED MEDICAL TECHNOLOGY, INC.

Enteral tube extension
Primary Device ID00842071132811
NIH Device Record Key8d7a682a-8aa9-437a-9db9-7962ddeb160a
Commercial Distribution StatusIn Commercial Distribution
Brand NameAMT MiniONE Extension Set
Version Model NumberE8-1224-ISOSAF
Catalog NumberE8-1224-ISOSAF, 8-1224-ISOSAF
Company DUNS038101861
Company NameAPPLIED MEDICAL TECHNOLOGY, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
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
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

Length12 Inch
Length12 Inch
Length12 Inch
Length12 Inch
Length12 Inch
Length12 Inch
Length12 Inch
Length12 Inch
Length12 Inch
Length12 Inch
Length12 Inch
Length12 Inch
Length12 Inch
Length12 Inch
Length12 Inch
Length12 Inch
Length12 Inch
Length12 Inch
Length12 Inch
Length12 Inch
Length12 Inch
Length12 Inch
Length12 Inch
Length12 Inch
Length12 Inch
Length12 Inch
Length12 Inch

Device Identifiers

Device Issuing AgencyDevice ID
GS100842071132811 [Package]
Contains: 00842071133078
Package: Box (8-1224-ISOSAF) [10 Units]
In Commercial Distribution
GS100842071133078 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KNTTubes, Gastrointestinal (And Accessories)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-07-29
Device Publish Date2024-07-19

On-Brand Devices [AMT MiniONE Extension Set]

0084207113291024" MiniONE Right Angle Feeding Set with Dual ENFit® Y-Port, Non-PVC (Pouched), MDR
0084207113290324" MiniONE Right Angle Feeding Set with ENFit® [ENFit®/Medication Port with Cap] (Pouched), M
0084207113289724" MiniONE Right Angle Locking Feeding Set with ENFit® (Pouched), MDR
0084207113288024" MiniONE Right Angle Feeding Set with Y-Port (Pouched), MDR
0084207113286624" MiniONE Right Angle Feeding Set with ENFit® and Cap (Pouched), MDR
0084207113285924" MiniONE Right Angle Feeding Set with Single Port (Pouched), MDR
0084207113284224" MiniONE Bolus Feeding Set with Single Port (Pouched), MDR
0084207113283512" MiniONE Right Angle Feeding Set with Dual ENFit® Y-Port, Non-PVC (Pouched), MDR
0084207113282812" MiniONE Right Angle Feeding Set with ENFit® and Cap (Pouched), MDR
0084207113281112" MiniONE Right Angle Feeding Set with ENFit® [ENFit®/Medication Port with Cap] (Pouched), M
0084207113279812" MiniONE Right Angle Locking Feed Set with ENFit® (Pouched), MDR
0084207113278112" MiniONE Right Angle Feeding Set with Y-Port (Pouched), MDR
0084207113276712" MiniONE Right Angle Feeding Set with ENFit® and Cap (Pouched), MDR
0084207113275012" MiniONE Right Angle Feeding Set with Single Port (Pouched), MDR
0084207113274312" MiniONE Bolus Feeding Set with Dual ENFit® Y-Port (Pouched), MDR
0084207113273612" MiniONE Bolus Feeding Set with Y-Port (Pouched), MDR
0084207113272912" MiniONE Bolus Feeding Set with ENFit® and Cap, Non-PVC (Pouched), MDR
008420711327122" MiniONE Right Angle Medication Set with Dual ENFit® Y-Port (Pouched), MDR
008420711327052" MiniONE Right Angle Medication Set with Y-Port (Pouched), MDR
008420711326992" MiniONE Medication Set with Dual ENFit® Y-Port (Pouched), MDR
008420711326822" MiniONE Medication Set with Y-Port (Pouched), MDR
008420711326752" MiniONE Medication Set with ENFit ® and Cap (Pouched), MDR
008420711326682" MiniONE Medication Set with Single Port (Pouched), MDR
0084207113265124" MiniONE Right Angle Feeding Set with Dual ENFit® Y-Port (Box 10), MDR
0084207113264424" MiniONE Right Angle Feeding Set with Single ENFit® Y-Port (Box 10), MDR
0084207113263724" MiniONE Right Angle Feeding Set with Y-Port (Box 10), MDR
0084207113262024" MiniONE Right Angle Feeding Set with ENFit® (Box 10), MDR
0084207113261324" MiniONE Right Angle Feeding Set with Dual ENFit® Y-Port (Box 10), MDR
0084207113260624" MiniONE Bolus Feeding Set with ENFit® and Cap (Box 10), MDR
0084207113259012" MiniONE Right Angle Feeding Set with Y-Port (Box 10), MDR
0084207113258312" MiniONE Right Angle Feeding Set with Dual ENFit® Y-Port (Box 10), MDR
0084207113257612" MiniONE Right Angle Feeding Set with Single ENFit® Y-Port (Box 10), MDR
0084207113256912" MiniONE Right Angle Feeding Set with Y-Port (Box 10), MDR
0084207113255212" MiniONE Right Angle Feeding Set with ENFit® (Box 10), MDR
0084207113254512" MiniONE Right Angle Feeding Set with Dual ENFit® Y-Port (Box 10), MDR
0084207113253812" MiniONE Bolus Feeding Set with ENFit® and Cap (Box 10), MDR
0084207113252112" MiniONE Bolus Feeding Set with Single Port (Box 10), MDR
0084207113237824" MiniONE Right Angle Feeding Set with Dual ENFit® Y-Port (Pouched), MDR
0084207113236124" MiniONE Right Angle Feeding Set with Single ENFit® Y-Port (Pouched), MDR
0084207113235424" MiniONE Right Angle Feeding Set with Y-Port (Pouched), MDR
0084207113234724" MiniONE Right Angle Feeding Set with ENFit® (Pouched), MDR
0084207113233024" MiniONE Right Angle Feeding Set with Dual ENFit® Y-Port (Pouched), MDR
0084207113232324" MiniONE Bolus Feeding Set with ENFit® and Cap (Pouched), MDR
0084207113231612" MiniONE Right Angle Feeding Set with Y-Port (Pouched), MDR
0084207113230912" MiniONE Right Angle Feeding Set with Dual ENFit® Y-Port (Pouched), MDR
0084207113229312" MiniONE Right Angle Feeding Set with Single ENFit® Y-Port (Pouched), MDR
0084207113228612" MiniONE Right Angle Feeding Set with Y-Port (Pouched), MDR
0084207113227912" MiniONE Right Angle Feeding Set with ENFit® (Pouched), MDR
0084207113226212" MiniONE Right Angle Feeding Set with Dual ENFit® Y-Port (Pouched), MDR
0084207113225512" MiniONE Bolus Feeding Set with ENFit® and Cap (Pouched), MDR
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