Synclara Cough System

Basic Information

• Brand Name: Synclara Cough System
• Primary DI: 00887761975613
• Version / Model: PSC1ACIE
• Company Name: HILL-ROM SERVICES PTE. LTD.
• Labeler DUNS: 595156263
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-12-02
• Public Version: 1
• Public Version Date: 2021-12-10
• Public Version Status: New
• Public Device Record Key: aec8485d-70bc-44f4-8e91-d257ca357a3e

Device Description

SYNCLARA SYSTEM, AC IRELAND

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• 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
NHJ	DEVICE, POSITIVE PRESSURE BREATHING, INTERMITTENT	Anesthesiology	868.5905	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36998	In-exsufflator	A portable, pneumatic, device that, through a rapid shift in pressure via a face mask, produces a high expiratory flow rate from the lungs, simulating a cough. This technique is referred to as EWNP (exsufflation with negative pressure) or mechanical insufflation-exsufflation. This device is suitable for any patient with an ineffective cough due to, e.g., muscular disorders or paralysis and would typically be used to clear retained broncho-pulmonary secretions, reducing the risk of respiratory complications.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00887761975613	GS1

Customer Contacts

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