AMT Mini ONE® Extension Set E8-0222-ISOSAF, 8-0222-ISOSAF

GUDID 00842071108540

2" Mini ONE® RIGHT ANGLE Medication Set with Dual ENFit ® Y-PORT (Pouched)

APPLIED MEDICAL TECHNOLOGY, INC.

Enteral tube extension, non-sterile Enteral tube extension Enteral tube extension Enteral tube extension Enteral tube extension Enteral tube extension Enteral tube extension Enteral tube extension Enteral tube extension Enteral tube extension Enteral tube extension Enteral tube extension Enteral tube extension Enteral tube extension Enteral tube extension Enteral tube extension Enteral tube extension Enteral tube extension Enteral tube extension
Primary Device ID00842071108540
NIH Device Record Key5cad38fa-1e8b-4f2a-bd37-b1dedf0bf5b3
Commercial Distribution StatusIn Commercial Distribution
Brand NameAMT Mini ONE® Extension Set
Version Model NumberE8-0222-ISOSAF
Catalog NumberE8-0222-ISOSAF, 8-0222-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

Device Dimensions

Length2 Inch
Length2 Inch
Length2 Inch
Length2 Inch
Length2 Inch
Length2 Inch
Length2 Inch
Length2 Inch
Length2 Inch
Length2 Inch
Length2 Inch
Length2 Inch
Length2 Inch
Length2 Inch
Length2 Inch
Length2 Inch
Length2 Inch
Length2 Inch
Length2 Inch

Device Identifiers

Device Issuing AgencyDevice ID
GS100842071107444 [Primary]
GS100842071108540 [Package]
Contains: 00842071107444
Package: Box (8-0222-ISOSAF) [10 Units]
In Commercial Distribution

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 Date2019-11-25
Device Publish Date2019-11-15

On-Brand Devices [AMT Mini ONE® Extension Set]

0084207111603312" Mini ONE® BOLUS Feeding Set with ENFit ® and Cap (Box 10)
0084207111602612" Mini ONE® BOLUS Feeding Set with SINGLE Port (Box 10)
0084207111495424" Mini ONE Feedset with Right Angle Adapter and Y-Port (Hybrid, Box 10)
0084207111494712" Mini ONE Feedset with Right Angle Adapter and Y-Port (Hybrid, Box 10)
0084207111464024" Mini ONE Feedset with Right Angle Adapter and Y-Port (Hybrid, pouched)
0084207111463312" Mini ONE Feedset with Right Angle Adapter and Y-Port (Hybrid, pouched)
0084207110902824" Mini ONE® RIGHT ANGLE Feeding Set with Y-PORT (Box 10)
0084207110884712" Mini ONE® RIGHT ANGLE GLOW GREEN Feeding Set with Y-PORT (Box 10)
0084207110880912" Mini ONE® RIGHT ANGLE GLOW GREEN Feeding Set with Y-PORT (Box 10)
0084207110878612" Mini ONE® RIGHT ANGLE Feeding Set with Y-PORT (Box 10)
0084207110904224" Mini ONE® RIGHT ANGLE Feeding Set with Dual ENFit ® Y-PORT (Pouched)
0084207110785724" Mini ONE® RIGHT ANGLE Feeding Set with Y-PORT (Pouched)
0084207110894624" Mini ONE® RIGHT ANGLE Feeding Set with ENFit ® (Pouched)
0084207110890824" Mini ONE® RIGHT ANGLE Feeding Set with Y-PORT (Pouched)
0084207110889224" Mini ONE® RIGHT ANGLE Feeding Set with ENFit ® and Cap (Pouched)
0084207110888524" Mini ONE® RIGHT ANGLE Feeding Set with SINGLE Port (Pouched)
0084207110887824" Mini ONE® BOLUS Feeding Set with ENFit ® and Cap (Pouched)
0084207110885424" Mini ONE® BOLUS Feeding Set with SINGLE Port (Pouched)
0084207110770312" Mini ONE® RIGHT ANGLE GLOW GREEN Feeding Set with Y-PORT (Pouched)
0084207110769712" Mini ONE® RIGHT ANGLE Feeding Set with Dual ENFit ® Y-PORT (Pouched)
0084207110766612" Mini ONE® RIGHT ANGLE GLOW GREEN Feeding Set with Y-PORT (Pouched)
0084207110765912" Mini ONE® RIGHT ANGLE Feeding Set with Y-PORT (Pouched)
0084207110868712" Mini ONE® RIGHT ANGLE Feeding Set with ENFit ® (Pouched)
0084207110864912" Mini ONE® RIGHT ANGLE Feeding Set with Y-PORT (Pouched)
0084207110863212" Mini ONE® RIGHT ANGLE Feeding Set with ENFit ® and Cap (Pouched)
0084207110862512" Mini ONE® RIGHT ANGLE Feeding Set with SINGLE port (Pouched)
0084207110859512" Mini ONE® BOLUS Feeding Set with Y-PORT (Pouched)
0084207110858812" Mini ONE® BOLUS Feeding Set with ENFit ® and Cap (Pouched)
0084207110856412" Mini ONE® BOLUS Feeding Set with SINGLE Port (Pouched)
008420711085332" Mini ONE® RIGHT ANGLE Medication Set with Y-PORT (Pouched)
008420711074062" Mini ONE® Medication Set with Y-Port (Pouched)
008420711084962" Mini ONE® Medication Set with ENFit ® and Cap (Pouched)
008420711084892" Mini ONE® Medication Set with Single Port (Pouched)
0084207110900424" Mini ONE® RIGHT ANGLE Feeding Set with ENFit ® [ENFit/Medication Port with Cap] (Pouched)
0084207110898424" Mini ONE® RIGHT ANGLE Feeding Set with ENFit ® (Pouched)
0084207110896024" Mini ONE® RIGHT ANGLE Locking Feeding Set with ENFit ® (Pouched)
0084207110892224" Mini ONE® RIGHT ANGLE Feeding Set with Dual ENFit ® Y-PORT (Pouched)
0084207110881612" Mini ONE® RIGHT ANGLE GLOW GREEN Feeding Set with Dual ENFit ® Y-PORT (Pouched)
0084207110876212" Mini ONE® Right Angle Feeding Set with ENFit ® and Cap (Pouched)
0084207110874812" Mini ONE® Right Angle feeding set with ENFit ® [ENFit/Medication Port with Cap] (Pouched)
0084207110872412" Mini ONE® RIGHT ANGLE Feeding Set with ENFit ® (Pouched)
0084207110870012" Mini ONE® RIGHT ANGLE Locking Feed Set with ENFit ® (Pouched)
0084207110866312" Mini ONE® RIGHT ANGLE Feeding Set with Dual ENFit ® Y-PORT (Pouched)
0084207110860112" Mini ONE® BOLUS Feeding Set with Dual ENFit ® Y-PORT (Pouched)
008420711085402" Mini ONE® RIGHT ANGLE Medication Set with Dual ENFit ® Y-PORT (Pouched)
008420711085192" Mini ONE® Medication Set with Dual ENFit ® Y-Port (Pouched)
0084207112926224" Mini ONE® RIGHT ANGLE Non-PVC Feeding Set with Dual ENFit ® Y-PORT (Pouched)
0084207112924812" Mini ONE® RIGHT ANGLE Non-PVC Feeding Set with Dual ENFit ® Y-PORT (Pouched)
0084207112921712" Mini ONE® BOLUS Non-PVC Feeding Set with ENFit® and Cap (Pouched)

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