FDA.report

Oxygen Kit

Primary DI
00848530093495
Brand
Oxygen Kit
Company
SUNSET HEALTHCARE SOLUTIONS, INC.
Model
RESO2KITANPL
Device description
RES1104 (2), RES3025G (2), RES012 (2), RES035 (1), RES032 (1)
Published
2024-07-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00848530093495PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00848530093495008485300934958485300934950848530093495

GMDN Terms

TermDefinition
Oxygen administration kitA collection of 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

Contacts

PhoneEmail
8775786738customerservice@sunsethcs.com

Regulatory Flags

DUNS number
141668116
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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10848530108219Oxygen, Bacteria & HEPA FilterOF7005-102026-03-09
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00848530108588Repair PartsRP102NS2026-03-09
10848530108356Vented CPAP Masks VC10092026-03-03
10848530108363Vented CPAP Masks VC10102026-03-03
10848530108370Vented CPAP Masks VC10112026-03-03
10848530108387Vented CPAP Masks VC10122026-03-03
00848530108427Ventilator FilterVF005-12026-02-20