FDA.reportPublic FDA data

DAR

Primary DI
20884521822860
Brand
DAR
Company
Covidien LP
Model
444SP01516
Device description
Closed Suction System Tracheostomy Length, MDI Port
Published
2025-01-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BSYCatheters, Suction, TracheobronchialAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884521822860PackageGS110In Commercial Distribution
10884521822863PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452182286020884521822860
1088452182286310884521822863

GMDN Terms#

Term, Definition table
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#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length365Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Fragile, Keep dry, This side up

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags#

DUNS number
058614483
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521141117WarmTouch50308902019-02-06
10884521205024Shiley4CN65R2016-09-24
10884521205420Shiley5CN70R2016-09-24
10884521205437Shiley6CN75R2016-09-24
10884521205444Shiley7CN80R2016-09-24
10884521205451Shiley8CN85R2016-09-24
10884521205468Shiley9CN90R2016-09-24
10884521205475Shiley10CN10R2016-09-24
10884521205482Shiley4UN65R2016-09-24
10884521205499Shiley5UN70R2016-09-24
10884521205505Shiley6UN75R2016-09-24
10884521205512Shiley7UN80R2016-09-24
10884521205529Shiley8UN85R2016-09-24
10884521205536Shiley9UN90R2016-09-24
10884521205543Shiley10UN10R2016-09-24
10884521815360NellcorMAXFAST2021-08-09
10884521815469NellcorMAXFASTI2021-08-09
10884521820890Mon-a-Therm900412023-05-29
10884521820906Mon-a-Therm900422023-05-29
10884521820913Mon-a-Therm900432023-05-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10889483564134BALLARD™SUNMED, LLCBSY2026-07-09
06925816656057Suction CatheterWell Lead Medical Co.,LtdBSY2026-06-03
10080196033553MEDLINEMEDLINE INDUSTRIES, INC.BSY2026-05-15
10889483564325BALLARD™SUNMED, LLCBSY2025-11-20
10889483623411BALLARD™SUNMED, LLCBSY2025-11-20
10704411012665AMSure® Closed Suction System for AdultsAMSINO INTERNATIONAL, INC.BSY2025-06-23
10704411012672AMSure® Closed Suction System for AdultsAMSINO INTERNATIONAL, INC.BSY2025-06-23
10704411012689AMSure® Closed Suction System for AdultsAMSINO INTERNATIONAL, INC.BSY2025-06-23
10704411012696AMSure® Closed Suction System for AdultsAMSINO INTERNATIONAL, INC.BSY2025-06-23
10704411012702AMSure® Closed Suction System for AdultsAMSINO INTERNATIONAL, INC.BSY2025-06-23
10704411012719AMSure® Closed Suction System for AdultsAMSINO INTERNATIONAL, INC.BSY2025-06-23
10704411012726AMSure® Closed Suction System for AdultsAMSINO INTERNATIONAL, INC.BSY2025-06-23
10704411012733AMSure® Closed Suction System for AdultsAMSINO INTERNATIONAL, INC.BSY2025-06-23
10704411012740AMSure® Closed Suction System for AdultsAMSINO INTERNATIONAL, INC.BSY2025-06-23
10704411012757AMSure® Closed Suction System for AdultsAMSINO INTERNATIONAL, INC.BSY2025-06-23
10704411012764AMSure® Closed Suction System for AdultsAMSINO INTERNATIONAL, INC.BSY2025-06-23
10704411012771AMSure® Closed Suction System for AdultsAMSINO INTERNATIONAL, INC.BSY2025-06-23
10704411012825AMSure® Closed Suction System for AdultsAMSINO INTERNATIONAL, INC.BSY2025-06-23
10704411012832AMSure® Closed Suction System for AdultsAMSINO INTERNATIONAL, INC.BSY2025-06-23
10704411012849AMSure® Closed Suction System for AdultsAMSINO INTERNATIONAL, INC.BSY2025-06-23
10704411012856AMSure® Closed Suction System for AdultsAMSINO INTERNATIONAL, INC.BSY2025-06-23
10704411012863AMSure® Closed Suction System for AdultsAMSINO INTERNATIONAL, INC.BSY2025-06-23
10704411012870AMSure® Closed Suction System for AdultsAMSINO INTERNATIONAL, INC.BSY2025-06-23
10704411012887AMSure® Closed Suction System for AdultsAMSINO INTERNATIONAL, INC.BSY2025-06-23
10704411012894AMSure® Closed Suction System for AdultsAMSINO INTERNATIONAL, INC.BSY2025-06-23
10704411012900AMSure® Closed Suction System for AdultsAMSINO INTERNATIONAL, INC.BSY2025-06-23
10704411012917AMSure® Closed Suction System for AdultsAMSINO INTERNATIONAL, INC.BSY2025-06-23
10704411012924AMSure® Closed Suction System for AdultsAMSINO INTERNATIONAL, INC.BSY2025-06-23
10704411012931AMSure® Closed Suction System for AdultsAMSINO INTERNATIONAL, INC.BSY2025-06-23
10704411018063AMSure® Closed Suction System For Neonates/pediatricsAMSINO INTERNATIONAL, INC.BSY2025-06-23