CPAP Carry Bag for ResMed AirSense 11

GUDID 10848530106710

CPAP Carry Bag

SUNSET HEALTHCARE SOLUTIONS, INC.

Medical bag
Primary Device ID10848530106710
NIH Device Record Keyd0ff7153-baa3-41d1-9ff2-578b95d6a081
Commercial Distribution StatusIn Commercial Distribution
Brand NameCPAP Carry Bag for ResMed AirSense 11
Version Model NumberCAP1028-S11
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 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

Phone8775786738
Emailcustomerservice@sunsethcs.com
Phone8775786738
Emailcustomerservice@sunsethcs.com
Phone8775786738
Emailcustomerservice@sunsethcs.com
Phone8775786738
Emailcustomerservice@sunsethcs.com
Phone8775786738
Emailcustomerservice@sunsethcs.com
Phone8775786738
Emailcustomerservice@sunsethcs.com
Phone8775786738
Emailcustomerservice@sunsethcs.com
Phone8775786738
Emailcustomerservice@sunsethcs.com
Phone8775786738
Emailcustomerservice@sunsethcs.com
Phone8775786738
Emailcustomerservice@sunsethcs.com
Phone8775786738
Emailcustomerservice@sunsethcs.com
Phone8775786738
Emailcustomerservice@sunsethcs.com
Phone8775786738
Emailcustomerservice@sunsethcs.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100848530106713 [Primary]
GS110848530106710 [Package]
Contains: 00848530106713
Package: [25 Units]
In Commercial Distribution

FDA Product Code

BZDVentilator, Non-Continuous (Respirator)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-07-29
Device Publish Date2025-07-21

Devices Manufactured by SUNSET HEALTHCARE SOLUTIONS, INC.

00848530106454 - Perform Health PrecisionFit Full Face CPAP Mask - Small2025-07-30 CPAP mask with cushion and headgear
00848530106461 - Peform Health PrecisionFit Full Face CPAP Mask - Mediom2025-07-30 CPAP mask with cushion and headgear
00848530106478 - Peform Health PrecisionFit Full Face CPAP Mask- Large2025-07-30 CPAP Mask with cushion and headgear - Large
00848530106485 - Perform Health PrecisionFit Full Face Cushion - Small2025-07-30 CPAP Cushion - Small
00848530106492 - Perform Health PrecisionFit Full Face Cushion - Medium2025-07-30 CPAP Cushion - Medium
00848530106508 - Perform Health PrecisionFit Full Face Cushion - Large2025-07-30 CPAP Cusion - Large
10848530106710 - CPAP Carry Bag for ResMed AirSense 112025-07-29CPAP Carry Bag
10848530106710 - CPAP Carry Bag for ResMed AirSense 112025-07-29 CPAP Carry Bag
00848530106447 - Oxygen Kit2025-07-25 Oxygen Kit- This kit: RES1107(4) RES3025 (2) RES032 (1) RES035 (1) RES012 (2) RES003 (1)

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