FDA.reportPublic FDA data

TELEFLEX

Primary DI
04026704400744
Brand
TELEFLEX
Company
TELEFLEX INCORPORATED
Model
IPN044918
Catalog number
5-23000
Device description
TELEFLEX ISIS™ SUCTION ACCESSORY PACK, STERILE
Published
2015-10-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BTRTube, tracheal (w/wo connector)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTRTube, Tracheal (W/Wo Connector)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K091761000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K091761000TELEFLEX ISIS HVT TRACHEAL TUBE, CUFFED, WITH SUBGLOTTIC SECRETION SUCTION PORTTeleflexmedical, Inc.2009-10-29BTR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
24026704400748PackageGS15In Commercial Distribution
44026704400742PackageGS18In Commercial Distribution
04026704400744PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2402670440074824026704400748
4402670440074244026704400742
04026704400744040267044007444026704400744

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
Height17Millimeter
Length255Millimeter
Width15Millimeter

Contacts#

Phone, Email table
PhoneEmail
+1(919)544-8000CS@TELEFLEX.COM

Regulatory Flags#

DUNS number
002348191
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10801902224931LMA AIRWAY MANAGEMENT105320-000010105320-0000102026-09-18
10801902172065ARROWIPN917285IAP-07002021-09-27
10801902187649ARROWIPN919474CS-12123-F2022-11-29
10801902215229ARROWIPN928089CS-12123-F2023-06-05
14026704633002DEKNATELIPN02854479-5562019-09-03
14026704633019DEKNATELIPN02854579-5602019-09-04
14026704633026DEKNATELIPN02854679-5982019-09-04
14026704633149DEKNATELIPN02855779-7752019-09-04
14026704633156DEKNATELIPN02855879-8122019-09-04
14026704633729DEKNATELIPN028759RC6-9702019-09-04
14026704633828DEKNATELIPN028581X-21612019-09-04
14026704633842DEKNATELIPN028658X-29722019-09-03
14026704633873DEKNATELIPN028583X-30192019-09-04
14026704633880DEKNATELIPN028763X-30272019-09-04
14026704633897DEKNATELIPN028764X-30942019-09-04
14026704633910DEKNATELIPN028584X-31422019-09-04
14026704633934DEKNATELIPN028766X-33412019-09-04
14026704633996DEKNATELIPN028769X-36342019-09-04
14026704634047DEKNATELIPN028773X-41942019-09-04
14026704634108DEKNATELIPN028661X-44342019-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
14026704934758LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDBTR2026-08-03
14026704934765LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDBTR2026-08-03
14026704934772LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDBTR2026-08-03
14026704934802LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDBTR2026-08-03
14026704759191SHERIDANTELEFLEX INCORPORATEDBTR2026-08-01
14026704759399SHERIDANTELEFLEX INCORPORATEDBTR2026-08-01
14026704759405SHERIDANTELEFLEX INCORPORATEDBTR2026-08-01
14026704759412SHERIDANTELEFLEX INCORPORATEDBTR2026-08-01
14026704759429SHERIDANTELEFLEX INCORPORATEDBTR2026-08-01
14026704759436SHERIDANTELEFLEX INCORPORATEDBTR2026-08-01
14026704759443SHERIDANTELEFLEX INCORPORATEDBTR2026-08-01
14026704759481SHERIDANTELEFLEX INCORPORATEDBTR2026-08-01
14026704759498SHERIDANTELEFLEX INCORPORATEDBTR2026-08-01
14026704759504SHERIDANTELEFLEX INCORPORATEDBTR2026-08-01
14026704759511SHERIDANTELEFLEX INCORPORATEDBTR2026-08-01
14026704759566SHERIDANTELEFLEX INCORPORATEDBTR2026-08-01
14026704759573SHERIDANTELEFLEX INCORPORATEDBTR2026-08-01
14026704759597SHERIDANTELEFLEX INCORPORATEDBTR2026-08-01
14026704759696SHERIDANTELEFLEX INCORPORATEDBTR2026-08-01
14026704759740SHERIDANTELEFLEX INCORPORATEDBTR2026-08-01
14026704759580SHERIDANTELEFLEX INCORPORATEDBTR2026-07-29
00810003750822KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-08
00810003750839KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-08
00810003750846KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-08
00810003750853ENTRONKENTRON HEALTHCARE, INC.BTR2026-06-08
00810003750860KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-08
00810003750877KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-08
00810003750884KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-08
00810003750891KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-08
00810003750907KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-08