BEUDAMED

FDA UDI In Commercial Distribution 🇺🇸 United States

S, AC611 HFNC, 22mm (M), JPN

DI: 00606959047853 · Model: 00 · Respironics, Inc.

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Product Codes

1

GMDN Terms

1

Identifiers

2

Pkg Device Count

1

Basic Information

Brand Name: S, AC611 HFNC, 22mm (M), JPN
Primary DI: 00606959047853
Version / Model: 00
Catalog Number: 1134604
Company Name: Respironics, Inc.
Labeler DUNS: 080728314
Distribution Status: In Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2020-03-12
Public Version: 2
Public Version Date: 2022-03-22
Public Version Status: Update
Public Device Record Key: 3e00bcb5-7d81-4149-9b64-70f1169c74c0

Device Description

Small, AC611 High Flow Nasal Cannula, 22mm (Male Connection), Japan

Device Characteristics

Single Use: Yes
Prescription Use (Rx): Yes
Over the Counter (OTC): No
Kit: No
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: Yes
Has Serial Number: No
Has Lot/Batch Number: Yes
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
CAT	CANNULA, NASAL, OXYGEN	Anesthesiology	868.5340	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35201	Nasal oxygen cannula, basic	A semi-rigid tube with nasal prongs designed to be inserted into the nostrils of a patient, and held in place with a headstrap, to administer oxygen (O2). It is commonly known as "nasal prongs". This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30606959047854	GS1	Multipack	10	In Commercial Distribution
Primary	00606959047853	GS1

Customer Contacts

Phone: +1(724)744-2500
Email: [email protected]

Storage Conditions

Type: Storage Environment Temperature
Temperature Range: -20 – 60 Degrees Celsius
Type: Storage Environment Humidity
Temperature Range: 15 – 95 Percent (%) Relative Humidity
Type: Storage Environment Temperature
Temperature Range: -4 – 140 Degrees Fahrenheit