FDA.report

Suction Catheter - 12Fr, Y-Valve, Straight, Calibrated

Primary DI
20848530081984
Brand
Suction Catheter - 12Fr, Y-Valve, Straight, Calibrated
Company
SUNSET HEALTHCARE SOLUTIONS, INC.
Model
TRASC112S
Catalog number
TRASC112S
Device description
Suction Catheter - 12Fr, Y-Valve, Straight, Calibrated (1/pack)
Published
2018-07-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
BSYCatheters, Suction, Tracheobronchial

Product Code Classifications

CodeDeviceSpecialtyClass
BSYCatheters, Suction, TracheobronchialAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10848530081987PackageGS150In Commercial Distribution
20848530081984PackageGS110In Commercial Distribution
00848530081980PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1084853008198710848530081987
2084853008198420848530081984
00848530081980008485300819808485300819800848530081980

GMDN Terms

TermDefinition
Tracheal suction catheterA flexible tube typically made of plastic designed for periodic aspiration of liquids and/or semi-solids from a patient's upper airway. The tube is usually 40 to 56 cm (16 to 22 inches) in length and of small enough diameter to fit through an endotracheal (ET) tube. It usually has a smooth and rounded distal-tip configuration, including end and side holes; most include a finger-controlled valve to regulate the suctioning pressure. The device is externally attached through a large-diameter extension tube to a vacuum system and collection jar; it is used to remove excessive internal secretions from the lungs, bronchi, trachea, and pharynx. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
877-578-6738customerservice@sunsethcs.com

Regulatory Flags

DUNS number
141668116
Device count
1
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
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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