Sunset Healthcare Solutions Disposable Nebulizer Kit w/T Mouthpiece RES091

GUDID 10848530060791

Adult Neb Kit - Disposable - w/ Jet Nebulizer, T-Piece, Mouthpiece, 6-inch Tube, 7ft O2 tube - 50/cs

SUNSET HEALTHCARE SOLUTIONS, INC.

Nebulizing system delivery set, single-use
Primary Device ID10848530060791
NIH Device Record Key7e31a41a-7153-4f2f-99df-3f600fe5e0e8
Commercial Distribution StatusIn Commercial Distribution
Brand NameSunset Healthcare Solutions Disposable Nebulizer Kit w/T Mouthpiece
Version Model NumberRES091
Catalog NumberRES091
Company DUNS141668116
Company NameSUNSET HEALTHCARE SOLUTIONS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone877-578-6738
Emailcustomerservice@sunsethcs.com
Phone877-578-6738
Emailcustomerservice@sunsethcs.com
Phone877-578-6738
Emailcustomerservice@sunsethcs.com
Phone877-578-6738
Emailcustomerservice@sunsethcs.com
Phone877-578-6738
Emailcustomerservice@sunsethcs.com
Phone877-578-6738
Emailcustomerservice@sunsethcs.com
Phone877-578-6738
Emailcustomerservice@sunsethcs.com
Phone877-578-6738
Emailcustomerservice@sunsethcs.com
Phone877-578-6738
Emailcustomerservice@sunsethcs.com
Phone877-578-6738
Emailcustomerservice@sunsethcs.com
Phone877-578-6738
Emailcustomerservice@sunsethcs.com
Phone877-578-6738
Emailcustomerservice@sunsethcs.com
Phone877-578-6738
Emailcustomerservice@sunsethcs.com

Device Dimensions

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Device Identifiers

Device Issuing AgencyDevice ID
GS100848530060794 [Primary]
GS110848530060791 [Package]
Contains: 00848530060794
Package: Corrugated Box [50 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CAFNebulizer (Direct Patient Interface)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-24

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