FDA.reportPublic FDA data

AMT Stiffener for Initial Placement

Primary DI
00842071131173
Brand
AMT Stiffener for Initial Placement
Company
APPLIED MEDICAL TECHNOLOGY, INC.
Model
E4-6200
Catalog number
E4-6200, 4-6200
Device description
Introducer / Stiffener for Initial Placement (Long Length, Pouched)
Published
2021-11-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KNTTubes, Gastrointestinal (And Accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNTTubes, Gastrointestinal (And Accessories)Gastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K042300000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K042300000AMT INTRODUCER: MINI BUTTON DELIVERY SYSTEMApplied Medical Technology, Inc.2004-10-25KNT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842071131173PackageGS110In Commercial Distribution
00842071131166PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842071131173008420711311738420711311730842071131173
00842071131166008420711311668420711311660842071131166

GMDN Terms#

Term, Definition table
TermDefinition
Peritoneal catheter styletA thin wire/rod intended to be inserted within the lumen of a peritoneal catheter (e.g., peritoneal dialysis catheter, peritoneal drainage catheter, peritoneal lavage catheter, abdominal fluid shunt system peritoneal catheter) to stiffen/maintain the shape of the catheter to assist introduction; it may also be intended to assist insertion of a bladder catheter used for drainage of fluid from the peritoneal cavity to the bladder. It is intended to be removed once the catheter is in place. This is a single-use device.

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
00842071146337MINI Balloon Button5-16105-16102026-10-20
00842071146344MINI Balloon Button5-1610-I5-1610-I2026-10-20
00842071146375MINI Balloon Button5-16155-16152026-10-20
00842071146382MINI Balloon Button5-1615-I5-1615-I2026-10-20
00842071146795MINI Balloon Button5-18445-18442026-10-20
00842071146801MINI Balloon Button5-1844-I5-1844-I2026-10-20
00842071147136MINI Balloon Button5-24205-24202026-10-20
00842071147143MINI Balloon Button5-2420-I5-2420-I2026-10-20
00842071147150MINI Balloon Button5-24235-24232026-10-20
00842071147167MINI Balloon Button5-2423-I5-2423-I2026-10-20
00842071147174MINI Balloon Button5-24255-24252026-10-20
00842071147181MINI Balloon Button5-2425-I5-2425-I2026-10-20
00842071147211MINI Balloon Button5-24305-24302026-10-20
00842071147228MINI Balloon Button5-2430-I5-2430-I2026-10-20
00842071147273MINI Balloon Button5-24445-24442026-10-20
00842071147280MINI Balloon Button5-2444-I5-2444-I2026-10-20
00842071146634MINI Balloon Button5-18175-18172026-10-19
00842071146641MINI Balloon Button5-1817-I5-1817-I2026-10-19
00842071146672MINI Balloon Button5-18235-18232026-10-19
00842071146689MINI Balloon Button5-1823-I5-1823-I2026-10-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00350770997780MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 20 Fr, OTWAvanos Medical, Inc.KNT2026-10-20
00350770997797MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 24 Fr, OTWAvanos Medical, Inc.KNT2026-10-20
00350770997834MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 14 Fr, PULLAvanos Medical, Inc.KNT2026-10-20
00350770997841MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 20 Fr, PULLAvanos Medical, Inc.KNT2026-10-20
00350770997858MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 24 Fr, PULLAvanos Medical, Inc.KNT2026-10-20
00350770997896MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 14 Fr, PULLAvanos Medical, Inc.KNT2026-10-20
00350770997902MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 20 Fr, PULLAvanos Medical, Inc.KNT2026-10-20
00350770997919MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 24 Fr, PULLAvanos Medical, Inc.KNT2026-10-20
00350770997964MIC* Percutaneous Endoscopic Gastrostomy (PEG) Kit, 20 Fr, PULLAvanos Medical, Inc.KNT2026-10-20
00350770997971MIC* Percutaneous Endoscopic Gastrostomy (PEG) Kit, 20 Fr, PULLAvanos Medical, Inc.KNT2026-10-20
00842071146337MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-20
00842071146344MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-20
00842071146375MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-20
00842071146382MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-20
00842071146795MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-20
00842071146801MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-20
00842071147136MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-20
00842071147143MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-20
00842071147150MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-20
00842071147167MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-20
00842071147174MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-20
00842071147181MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-20
00842071147211MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-20
00842071147228MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-20
00842071147273MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-20
00842071147280MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-20
00842071146634MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-19
00842071146641MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-19
00842071146672MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-19
00842071146689MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-19