FDA.report

DAR

Primary DI
20884521822945
Brand
DAR
Company
Covidien LP
Model
444SP02116
Device description
Closed Suction System, Replaceable Catheter Endotracheal Length, MDI Port;Model DETACH. DSE - MDI PORT
Published
2023-08-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
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
20884521822945PackageGS110In Commercial Distribution
10884521822948PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2088452182294520884521822945
1088452182294810884521822948

GMDN Terms

TermDefinition
Suction system catheter, general-purposeA sterile flexible tube used in the removal of fluids from the body via a natural body orifice, surgical incision, or wound. It is typically designed to be attached to a collection canister or bottle where a vacuum is created by a suction system via an intermediate tubing. This is a single-use device.

Device Sizes

TypeValueUnit
Device Size Text, specify0
Length580Millimeter
Outer Diameter5.33Millimeter

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Fragile, Keep dry, This side up

Sterilization Methods

Method

Contacts

PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags

DUNS number
058614483
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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20884521841861Shiley70FXLTIN2026-03-16

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