FDA.reportPublic FDA data

AMT Mini ONE® Extension Set

Primary DI
00842071129262
Brand
AMT Mini ONE® Extension Set
Company
APPLIED MEDICAL TECHNOLOGY, INC.
Model
E8-2455-ISOSAF-NP
Catalog number
E8-2455-ISOSAF-NP; 8-2455-ISOSAF-NP
Device description
24" Mini ONE® RIGHT ANGLE Non-PVC Feeding Set with Dual ENFit ® Y-PORT (Pouched)
Published
2021-11-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
00842071129262PackageGS110In Commercial Distribution
00842071129101PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842071129262008420711292628420711292620842071129262
00842071129101008420711291018420711291010842071129101

GMDN Terms#

Term, Definition table
TermDefinition
Enteral tube extension, non-sterileA non-sterile, thin, flexible tube intended for extracorporeal connection to an enteral feeding tube (e.g., nasogastric tube) to increase the length of tubing from the patient to an oral/enteral device (e.g., syringe) during enteral feeding/medication administration or aspiration. It is typically a single-lumen, rubber or plastic tube of various diameters/lengths. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length24Inch

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
038101861
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
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
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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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
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10192253007572ArgyleCardinal Health 200, LLCPIF2025-04-24
10192253007596ArgyleCardinal Health 200, LLCPIF2025-04-24
10192253007619ArgyleCardinal Health 200, LLCPIF2025-04-24
10192253007633ArgyleCardinal Health 200, LLCPIF2025-04-24