FDA.reportPublic FDA data

Firesafe Connector Kit

Primary DI
00848530062125
Brand
Firesafe Connector Kit
Company
SUNSET HEALTHCARE SOLUTIONS, INC.
Model
RES010KIT
Catalog number
RES010KIT
Device description
This kit contains: 2 RES010 Firesafe Bidirectional Thermal Shut-Off Cannula Valves, 1 RES010TC Firesafe Tubing Connector.
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
00848530062125PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00848530062125008485300621258485300621250848530062125

GMDN Terms#

Term, Definition table
TermDefinition
Fire safety valveA non-sterile safety device intended to be integrated into oxygen delivery tubing to automatically stop the flow of oxygen and isolate the oxygen supply in the event of a fire. It typically consists of a small two-way tubing connector containing a thermal fuse. This is a single-patient, reusable 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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