CPAP Kit

GUDID 00848530092986

Ascend Nasal Medium Kit 2 Cushions

SUNSET HEALTHCARE SOLUTIONS, INC.

Aerosol face mask, rebreathing, single-use Aerosol face mask, rebreathing, single-use Aerosol face mask, rebreathing, single-use Aerosol face mask, rebreathing, single-use Aerosol face mask, rebreathing, single-use Aerosol face mask, rebreathing, single-use Aerosol face mask, rebreathing, single-use Aerosol face mask, rebreathing, single-use Aerosol face mask, rebreathing, single-use Aerosol face mask, rebreathing, single-use Aerosol face mask, rebreathing, single-use Aerosol face mask, rebreathing, single-use Aerosol face mask, rebreathing, single-use Aerosol face mask, rebreathing, single-use
Primary Device ID00848530092986
NIH Device Record Keyc12ea7ec-6f44-45ca-ae16-f61527b9b658
Commercial Distribution StatusIn Commercial Distribution
Brand NameCPAP Kit
Version Model NumberAME038CM037NMKIT2
Company DUNS141668116
Company NameSUNSET HEALTHCARE SOLUTIONS, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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 Perscriptiontrue
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
Phone877-578-6738
Emailcustomerservice@sunsethcs.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100848530092986 [Primary]

FDA Product Code

BYFMask, Oxygen, Low Concentration, Venturi

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-06-17
Device Publish Date2024-06-08

On-Brand Devices [CPAP Kit]

00860005613274(26) CF1009NT-1PL, (4) CF1009F-1PL
00848530100858(1) TUB06 (1) RES3007 (1) RES019NS (1) BF220NS
008485300901351 TUB06, 4 CF1010NS
008485300901281 TUB06, 5 CF1010NS
00848530093013Ascend FF Small Kit
00848530093006Ascend FF Large Kit
00848530092993Ascend Nasal Small Kit 2 Cushions
00848530092986Ascend Nasal Medium Kit 2 Cushions
00848530092979Ascend Nasal Large Kit 2 Cushions
00848530092962Ascend Nasal Small Kit 5 Cushions
00848530092955Ascend Nasal Medium Kit 5 Cushions
00848530092948Ascend Nasal Large Kit 5 Cushions
00848530092931Ascend FF Medium Kit
00848530092818Complete Mask Kit
00860004356202ASNU001DSLGPK
00848530093242ASLE090CPAPKITA
00848530092665ACPA007CPAPKITDS
00848530092658CPAP Kit - ACPA007CPAPKITAS
00848530091552AISI001CM006M
00848530091545AISI001CM006S
00848530091330ASIM007DSKIT
00848530087234AINT014CF2107Combo
00848530087227AINT014CF1010combo
00848530082277APAR008TUB06CF1007C2
00848530082260APAR008TUB06CF1009NT
00848530081089TUB006SSCF2107PL
00850035116371Halo Style Chinstrap
00848530001322PR System One Remstar COMBO PACK **6 CF1009NT 1 CF1009F**

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