Timeter

Basic Information

• Brand Name: Timeter
• Primary DI: 00026072001622
• Version / Model: 15100
• Catalog Number: T15100
• Company Name: ALLIED HEALTHCARE PRODUCTS, INC.
• Labeler DUNS: 099674145
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-11-30
• Public Version: 4
• Public Version Date: 2020-01-13
• Public Version Status: Update
• Public Device Record Key: 6902f7e5-4f5e-4840-8ed5-b0328608649a

Device Description

Assembly, Top, 115 V, CAM 4

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• 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: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BYK	Tent, Oxygen, Electrically Powered	Anesthesiology	868.5710	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45545	Oxygen administration tent, neonatal/paediatric	A flexible enclosure designed to cover the bed of a neonatal or small child to provide an enriched environment of oxygen (O2) to increase the patient's O2 uptake. It is connected to an O2 source and may be used concurrently with increased humidification and temperature control. It typically consists of a metal frame covered with transparent plastic, the tubing, and may have built-in humidification. It is used for the treatment of breathing disorders in infant and paediatric patients permitting them movement without restriction. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00026072001622	GS1

Premarket Submissions

Submission Number	Supplement Number
K941547	000