50ft O2 Delivery Tube TAV, 1PK

Basic Information

• Brand Name: 50ft O2 Delivery Tube TAV, 1PK
• Primary DI: 00817131020407
• Version / Model: RP-1012
• Catalog Number: RP-1012
• Company Name: INOGEN, INC.
• Labeler DUNS: 136729634
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-03-20
• Public Version: 2
• Public Version Date: 2022-08-05
• Public Version Status: Update
• Public Device Record Key: aac57142-27ac-4db6-b490-9a8e0f73c57b

Device Description

50ft O2 Delivery Tube TAV, 1PK, RP-1012

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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
ONZ	Mechanical Ventilator	Anesthesiology	868.5895	2

GMDN Terms

Code	Name	Definition	Implantable	Status
12875	Oxygen administration tubing	A length of flexible noninvasive tube, typically a small bore, thick-walled, anti-kink tubing (to prevent blockage) intended for the delivery of a pure oxygen (O2), or an O2 enriched gas, to a mask or nasal cannula (not included), during delivery of dry O2 to the patient. The tubing is typically available in standard coil lengths and is cut by clinical staff to appropriate lengths to create an extension or connecting piece. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00817131020346	GS1	RP-1003	2	In Commercial Distribution
Primary	00817131020407	GS1

Premarket Submissions

Submission Number	Supplement Number
K152664	000

Storage Conditions

• Type: Handling Environment Humidity
• Temperature Range: 15 – 93 Percent (%) Relative Humidity
• Type: Storage Environment Humidity
• Temperature Range: 15 – 93 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 5 – 40 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: -25 – 70 Degrees Celsius