FDA.reportPublic FDA data

AMT Y-Port Accessory

Primary DI
00842071133566
Brand
AMT Y-Port Accessory
Company
APPLIED MEDICAL TECHNOLOGY, INC.
Model
E4-0005-ISOSAF
Catalog number
E4-0005-ISOSAF, 4-0005-ISOSAF
Device description
Dual ENFit Y-Port Accessory (Pouched), MDR
Published
2025-10-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PIFGastrointestinal Tubes With Enteral Specific Connectors

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PIFGastrointestinal Tubes With Enteral Specific ConnectorsGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K142989000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142989000Mini ONE Enteral Extension SetApplied Medical Technology, Inc.2015-01-29PIF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842071133573PackageGS110In Commercial Distribution
00842071133566PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842071133573008420711335738420711335730842071133573
00842071133566008420711335668420711335660842071133566

GMDN Terms#

Term, Definition table
TermDefinition
ENFit/ENFit linear connectorA small, non-powered, noninvasive, tubular, two-way/linear connector with an ENFit connection (designed according to ISO 80369-3 for enteral applications) at both ends intended to connect two enteral devices (e.g., enteral syringe, feeding tube, administration set) with each other; it does not have a Luer connection(s) (neither lock nor slip), and does not incorporate a filter, valve, clamp nor tubing. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
(440) 717-4000cs@appliedmedical.net

Regulatory Flags#

DUNS number
038101861
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
00842071153144AMT MiniONE Extension SetE8-2455-ISOSAFE8-2455-ISOSAF, 8-2455-ISOSAF2026-05-13
00842071147198MINI Balloon Button5-24272026-05-07
00842071147204MINI Balloon Button5-2427-I5-2427-I2026-05-07
00842071153045AMT MiniSPC Drainage SetES1-1221ES1-1221, S1-12212026-04-28
00842071153069AMT MiniSPC Drainage SetES1-2421ES1-2421, S1-24212026-04-28
00842071146276MINI Balloon Button5-14555-14552026-04-09
00842071146283MINI Balloon Button5-1455-I5-1455-I2026-04-09
00842071148935GEMINI Suture LoopES4-8000ES4-8000, S4-80002025-04-07
00842071151119RHAPSOESD110-S-07ESD110-S-07, SD110-S-07-101, SD110-S-07-1052026-03-25
00842071151140RHAPSOESD110-C-07ESD110-C-07, SD110-C-07-101, SD110-C-07-1052026-03-25
00842071153021AMT MiniONE Extension SetE8-1255-ISOSAFE8-1255-ISOSAF, 8-1255-ISOSAF2026-03-23
00842071153038AMT MiniONE Extension SetE8-1255-ISOSAFE8-1255-ISOSAF, 8-1255-ISOSAF2026-03-23
00842071150952AMT MiniSPC Drainage SetES1-1221ES1-1221, S1-12212026-03-18
00842071150976AMT MiniSPC Drainage SetES1-2421ES1-2421, S1-24212026-03-18
00842071152758MiniSPC ButtonSPC-2425-12SPC-2425-122026-03-18
00842071152765MiniSPC ButtonSPC-2425-24SPC-2425-242026-03-18
00842071152772MiniSPC ButtonSPC-2427-12SPC-2427-122026-03-18
00842071152789MiniSPC ButtonSPC-2427-24SPC-2427-242026-03-18
00842071152796MiniSPC ButtonSPC-2430-12SPC-2430-122026-03-18
00842071152802MiniSPC ButtonSPC-2430-24SPC-2430-242026-03-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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10192253012484Salem SumpCardinal Health 200, LLCPIF2026-03-19
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10192253012521Salem SumpCardinal Health 200, LLCPIF2026-03-19
10192253012989Salem SumpCardinal Health 200, LLCPIF2026-03-19
10192253013009Salem SumpCardinal Health 200, LLCPIF2026-03-19
10192253060928Salem SumpCardinal Health 200, LLCPIF2026-03-19
10192253068764CARDINAL HEALTHCardinal Health 200, LLCPIF2026-02-25
10192253068771CARDINAL HEALTHCardinal Health 200, LLCPIF2026-02-25
10192253068788CARDINAL HEALTHCardinal Health 200, LLCPIF2026-02-25
10192253068795CARDINAL HEALTHCardinal Health 200, LLCPIF2026-02-25
10192253068801CARDINAL HEALTHCardinal Health 200, LLCPIF2026-02-25
10192253068818CARDINAL HEALTHCardinal Health 200, LLCPIF2026-02-25
10192253068825CARDINAL HEALTHCardinal Health 200, LLCPIF2026-02-25
10192253068832CARDINAL HEALTHCardinal Health 200, LLCPIF2026-02-25
10192253011449CARDINAL HEALTHCardinal Health 200, LLCPIF2025-12-19
10192253011463CARDINAL HEALTHCardinal Health 200, LLCPIF2025-12-19
10192253011487CARDINAL HEALTHCardinal Health 200, LLCPIF2025-12-19
10192253011517CARDINAL HEALTHCardinal Health 200, LLCPIF2025-12-19
10192253011531CARDINAL HEALTHCardinal Health 200, LLCPIF2025-12-19
10192253011555CARDINAL HEALTHCardinal Health 200, LLCPIF2025-12-19
10192253011579CARDINAL HEALTHCardinal Health 200, LLCPIF2025-12-19
10192253011593CARDINAL HEALTHCardinal Health 200, LLCPIF2025-12-19
10192253011616CARDINAL HEALTHCardinal Health 200, LLCPIF2025-12-19
10850016172485KBMEDKB Medical (group), Inc.PIF2025-05-21
10850016172492KBMEDKB Medical (group), Inc.PIF2025-05-21
10192253007572ArgyleCardinal Health 200, LLCPIF2025-04-24
10192253007596ArgyleCardinal Health 200, LLCPIF2025-04-24
10192253007619ArgyleCardinal Health 200, LLCPIF2025-04-24
10192253007633ArgyleCardinal Health 200, LLCPIF2025-04-24