FDA.reportPublic FDA data

Patient O2 Kit

Primary DI
00848530088774
Brand
Patient O2 Kit
Company
SUNSET HEALTHCARE SOLUTIONS, INC.
Model
AMED034RESO2KIT
Catalog number
AMED034RESO2KIT
Device description
This Kit Contains: 1 RES018 Tubing Connector with Swivel, 1 RES002 Oxygen Connector with Swivel, 2 RES012 Tubing Connector, 3 RES1107 Adult Cannula with 7ft Supply Tubing, 1 RES050 Bubble Humidifier, 1 RES3025 Oxygen Tubing 25ft, 2 RES003 Oxygen In Use Sign, 1 RES031 Cylinder Wrench with Chain.
Published
2018-07-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10848530088771PackageGS125In Commercial Distribution
00848530088774PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084853008877110848530088771
00848530088774008485300887748485300887740848530088774

GMDN Terms#

Term, Definition table
TermDefinition
Oxygen administration kit, non-sterileA collection of non-sterile devices designed for oxygen (O2) delivery that may include a mask, a nasal cannula, oxygen tubing, disposable non-prefilled humidifier and connectors. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
877-578-6738customerservice@sunsethcs.com

Regulatory Flags#

DUNS number
141668116
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true

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Primary DI, Brand, Model table
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00848530086992Personal Device HolderCSBML6-Hardshell2024-06-28
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00848530080150Comfort Shoulder Bag for B/M6 CylindersCSBM6CSBM62018-07-31
00848530080167Backpack for B/M6, C/M9 or Smaller CylindersCSBM6BPCSBM6BP2018-07-31
00848530080174Comfort Shoulder Bag for C/M9 CylindersCSBM9CSBM92018-07-31
00848530081942Flex O2 BagCSBM6FlexCSBM6Flex2018-07-31
00848530087173Backpack for D CylindersCSBDBPCSBDBP2018-07-31
00848530087784Cylinder Roller Bag & Backpack — Single D/E TankCSBD1RollerCSBD1Roller2018-07-31
00848530087968Bag for Compressor NebulizerNEB100-BAGNEB100-BAG2018-05-29
00848530108939Ventilator FilterVF005-22026-04-30
00848530108946Ventilator FilterVF003-22026-04-30
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00848530108847CPAP FilterCF1012-2PLC2026-04-27