FDA.report

Suction Canister Supplies

Primary DI
20848530086224
Brand
Suction Canister Supplies
Company
SUNSET HEALTHCARE SOLUTIONS, INC.
Model
RES023S
Device description
Sunset 800cc Suction Canister -10/case
Published
2024-07-31
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
false

Related Records

Product Codes

CodeName
CANRegulator, Pressure, Gas Cylinder

Product Code Classifications

CodeDeviceSpecialtyClass
CANRegulator, Pressure, Gas CylinderAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00848530086220PrimaryGS10
20848530086224Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00848530086220008485300862208485300862200848530086220
2084853008622420848530086224

GMDN Terms

TermDefinition
Suction/irrigation system canister/bottle holder, reusableA device intended to be used to hold a dedicated fluid or collection/specimen canister or bottle that is used within a suction and/or irrigation system. This device can be used to mount the canister/bottle(s) to the parent system when it is mobile (on wheels), or to mount the canister/bottle to a medical device service rail system or a wall rail (typically used on the ward). This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
141668116
Device count
40
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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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