AMT Balloon Stoma Measurement Device

Basic Information

• Brand Name: AMT Balloon Stoma Measurement Device
• Primary DI: 00842071106805
• Version / Model: E1704
• Catalog Number: E1704, 1704
• Company Name: APPLIED MEDICAL TECHNOLOGY, INC.
• Labeler DUNS: 038101861
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-31
• Public Version: 7
• Public Version Date: 2021-10-29
• Public Version Status: Update
• Public Device Record Key: f45903b2-91c8-4173-90f4-016c47d9ce8a

Device Description

Balloon Stoma Measuring Device (Pouched)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	876.5980	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44796	Medical ruler, reusable	A small straight-edged strip intended to be used to measure the length of internal or external anatomy, devices or instruments in a clinical setting. It is marked in units of length (i.e., inches, millimetres and/or centimetres), and may be an independent bendable strip applied to measured surfaces or a strip incorporated into a form convenient for measuring specific devices (e.g., screws). It is not dedicated to wound measurements. This is a reusable device.	No	Active
63942	Gastrostomy depth sizer	A device intended to be used to measure the depth of a gastrointestinal stoma, from its opening to its terminus within the body, to help in the selection of an appropriately sized gastrostomy appliance (gastrostomy tube). It is typically in the form of a graduated catheter, intended to be inserted into the stoma, which may include an inflatable balloon at the distal end to secure its position after insertion. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00842071106829	GS1	Box (1704)	10	In Commercial Distribution
Primary	00842071106805	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K973893	000