FDA.reportPublic FDA data

DAR

Primary DI
10884521100497
Brand
DAR
Company
Covidien LP
Model
444SP01112
Device description
Closed Suction System,Endotracheal 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
10884521100497PackageGS110In Commercial Distribution
20884521100494PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088452110049710884521100497
2088452110049420884521100494

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
Catheter Gauge12French
Length580Millimeter

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
10884521032903BiosynGMT-2262015-09-01
10884521102163Vascufil88864788-05V2015-08-31
10884521833012BeaconN-19-052026-09-05
10884521833029BeaconN-22-052026-09-05
10884521833036BeaconN-25-052026-09-05
10884521833043SharkCoreDSC-22-012026-09-06
10884521833050SharkCoreDSC-25-012026-09-06
10884521833067SharkCoreC-22-052026-09-06
10884521833074SharkCoreC-25-052026-09-06
10884521833081SharkCoreDSL-19-012026-09-06
10884521833142BeaconDSN-19-012026-09-05
10884521833159BeaconDSN-22-012026-09-05
10884521833166BeaconDSN-25-012026-09-05
10884521197701superDimensionSDC102016-09-24
10884521198777superDimensionSDC202016-09-24
10884521198784superDimensionSDC52016-09-24
10884521198791superDimensionSDM22016-09-24
10884521198807superDimensionSDM32016-09-24
10884521539709SuperLockSDGN4472016-09-24
10884521757868Maxon8886621943-22020-01-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840117351875Resp-O2 Single Suction Catheters, Pediatric Graduated CatheterDynarex CorporationBSY2026-07-31
00840117351905Resp-O2 Single Suction Catheters, Pediatric Graduated Catheter, Control ValveDynarex CorporationBSY2026-07-31
00840117351936Resp-O2 Single Suction Catheters, Adult Graduated Catheter, Control ValveDynarex CorporationBSY2026-07-31
00840117351967Resp-O2 Single Suction Catheters, Adult Graduated Catheter, Control ValveDynarex CorporationBSY2026-07-31
00840117351998Resp-O2 Single Suction Catheters, Adult Graduated Catheter, Control ValveDynarex CorporationBSY2026-07-31
00840117352025Resp-O2 Single Suction Catheters, Adult Graduated Catheter, Control ValveDynarex CorporationBSY2026-07-31
00840117352056Resp-O2 Single Suction Catheters, Adult Graduated Catheter, Control ValveDynarex CorporationBSY2026-07-31
04719874954611Create BiotechCREATE BIOTECH CO., LTD.BSY2026-07-16
04719874957667Create BiotechCREATE BIOTECH CO., LTD.BSY2026-07-16
04719874958459Create BiotechCREATE BIOTECH CO., LTD.BSY2026-07-16
10889483564134BALLARD™SUNMED, LLCBSY2026-07-09
06925816656057Suction CatheterWell Lead Medical Co.,LtdBSY2026-06-03
00840117344761Resp-O2 Closed Suction Endotracheal Catheter, Y-Adaptor, InfantDynarex CorporationBSY2026-05-25
00840117344778Resp-O2 Closed Suction Endotracheal Catheter, Elbow, InfantDynarex CorporationBSY2026-05-25
00840117346215Resp-O2 Closed Suction Endotracheal Catheter, Elbow, PediatricDynarex CorporationBSY2026-05-25
00840117344204Resp-O2 Vexta72 Closed Suction Endotracheal Catheter, T-Piece, PediatricDynarex CorporationBSY2026-05-18
00840117344211Resp-O2 Vexta72 Closed Suction Endotracheal Catheter, T-Piece, Adult/PediatricDynarex CorporationBSY2026-05-18
00840117344228Resp-O2 Vexta72 Closed Suction Endotracheal Catheter, T-Piece, AdultDynarex CorporationBSY2026-05-18
00840117344242Resp-O2 Vexta72 Closed Suction Endotracheal Catheter, Double Swivel Elbow (DSE)Dynarex CorporationBSY2026-05-18
00840117344259Resp-O2 Vexta72 Closed Suction Endotracheal Catheter, Double Swivel Elbow (DSE)Dynarex CorporationBSY2026-05-18
00840117344266Resp-O2 Vexta72 Closed Suction Endotracheal Catheter, Double Swivel Elbow (DSE)Dynarex CorporationBSY2026-05-18
00840117344747Resp-O2 Closed Suction Tracheal Catheter, Elbow, InfantDynarex CorporationBSY2026-05-18
00840117344754Resp-O2 Closed Suction Tracheal Catheter, Elbow, PediatricDynarex CorporationBSY2026-05-18
10080196033553MEDLINEMEDLINE INDUSTRIES, INC.BSY2026-05-15
10889483623565BALLARD™SUNMED, LLCBSY2026-01-16
00840117344136Resp-O2 Vexta72 Closed Suction Tracheal Catheter, T-Piece, Adult/PediatricDynarex CorporationBSY2026-01-05
00840117344143Resp-O2 Vexta72 Closed Suction Tracheal Catheter, T-Piece, AdultDynarex CorporationBSY2026-01-05
00840117344167Resp-O2 Vexta72 Closed Suction Tracheal CatheterDynarex CorporationBSY2026-01-05
00840117344174Resp-O2 Vexta72 Closed Suction Tracheal Catheter, Double Swivel Elbow (DSE)Dynarex CorporationBSY2026-01-05
00840117344181Resp-O2 Vexta72 Closed Suction Tracheal Catheter, Double Swivel Elbow (DSE)Dynarex CorporationBSY2026-01-05