Synclara Cough System

GUDID 00887761985025

Respiratory Care

HILL-ROM SERVICES PTE. LTD.

In-exsufflator In-exsufflator In-exsufflator In-exsufflator
Primary Device ID00887761985025
NIH Device Record Key0af8a568-827e-48c4-b190-59926f4e027f
Commercial Distribution StatusIn Commercial Distribution
Brand NameSynclara Cough System
Version Model NumberM08084
Company DUNS595156263
Company NameHILL-ROM SERVICES PTE. LTD.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)445-3730
Emailus.customerservice@hillrom.com
Phone+1(800)445-3730
Emailus.customerservice@hillrom.com
Phone+1(800)445-3730
Emailus.customerservice@hillrom.com
Phone+1(800)445-3730
Emailus.customerservice@hillrom.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100887761985025 [Primary]
GS110887761985022 [Package]
Package: [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHJDEVICE, POSITIVE PRESSURE BREATHING, INTERMITTENT

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-03-16
Device Publish Date2020-03-06

On-Brand Devices [Synclara Cough System]

00887761984554Respiratory Care
00887761995062Respiratory Care
00887761984592Respiratory Care
00887761984547Respiratory Care
00887761985025Respiratory Care
00887761984530Respiratory Care
00887761975613SYNCLARA SYSTEM, AC IRELAND
00887761975606SYNCLARA SYSTEM, HC IRELAND
00887761975576SYNCLARA, AC, IE
00887761975569SYNCLARA, HC, IE

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