O2 Starter Kit

Primary DI
00848530084301
Brand
O2 Starter Kit
Company
Sunset Healthcare Solutions, Inc.
Model
APRO025RESO2KIT
Catalog number
APRO025RESO2KIT
Device description
This kit contains: 1 RES032 Cylinder Wrench, 1 RES012 Tubing Connector, 1 RES018 Tubing Connector with Swivel, 1 RES035 Brass Washer with Rubber Ring, 2 RES003 Oxygen In Use Sign, 2 RES1107 Adult Oxygen Cannula with 7ft Tubing.
Published
2018-07-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00848530084301PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00848530084301008485300843018485300843010848530084301

GMDN Terms#

Term, Definition table
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.

Contacts#

Phone, Email table
PhoneEmail
877-578-6738customerservice@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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Primary DI, Brand, Model table
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