FDA.reportPublic FDA data

RUSCH

Primary DI
44026704302152
Brand
RUSCH
Company
TELEFLEX INCORPORATED
Model
IPN050004
Catalog number
264030
Device description
St. Bartholomew Catheter with 250cc Balloon
Published
2016-09-16
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KNTTUBES, GASTROINTESTINAL (AND ACCESSORIES)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNTTubes, Gastrointestinal (And Accessories)Gastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K841036000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K841036000RECTAL BALLOON CATHETERSInmed Corp.1984-04-13KNT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
24026704302158PackageGS11Not in Commercial Distribution
44026704302152PackageGS110Not in Commercial Distribution
04026704302154PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2402670430215824026704302158
4402670430215244026704302152
04026704302154040267043021544026704302154

GMDN Terms#

Term, Definition table
TermDefinition
Barium enema catheterA flexible tube designed to administer barium, a contrast medium, into the lower gastrointestinal tract by way of the rectum, for radiographic visualization of the area; it may additionally be intended for washing of the colon. The rubber or plastic tube may also be used for colonoscopy and can have a silicone rubber retention balloon tip for the examination of incontinent persons. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
002348191
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10801902222920ARROWIPN931154CV-15703-E2026-05-20
10801902222937ARROWIPN931155CV-158022026-05-20
10801902222944ARROWIPN931156CV-16702-E2026-05-20
10841495149792QUIKCLOT6366362026-05-18
10841156105907VSIIPN00174679602020-01-27
10841156105914VSIIPN00174979612020-01-27
10841156105921VSIIPN00175279622020-02-06
10841156105938VSIIPN00175679642020-01-27
10841156105945VSIIPN00175979652020-02-06
10841156105952VSIIPN00176379712020-01-27
14026704942456RUSCH221800-000160221800-0001602026-05-15
14026704942463RUSCH221800-000180221800-0001802026-05-15
14026704942470RUSCH221800-000200221800-0002002026-05-15
14026704942487RUSCH221800-000220221800-0002202026-05-15
14026704942494RUSCH221800-000240221800-0002402026-05-15
14026704942500RUSCH221800-000120221800-0001202026-05-15
14026704942517RUSCH221800-000140221800-0001402026-05-15
10801902226096ARROWIPNB00593ASK-15703-BFL2026-05-14
10801902226102ARROWIPNB00594ASK-12703-BFL2026-05-14
14026704921321WECKIPN928663HOL2LG2025-08-25

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10192253006865Salem SumpCardinal Health 200, LLCKNT2026-01-16
10192253011449CARDINAL HEALTHCardinal Health 200, LLCKNT2025-12-19
10192253011463CARDINAL HEALTHCardinal Health 200, LLCKNT2025-12-19
10192253011487CARDINAL HEALTHCardinal Health 200, LLCKNT2025-12-19
10192253011517CARDINAL HEALTHCardinal Health 200, LLCKNT2025-12-19
10192253011531CARDINAL HEALTHCardinal Health 200, LLCKNT2025-12-19
10192253011555CARDINAL HEALTHCardinal Health 200, LLCKNT2025-12-19
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10192253011593CARDINAL HEALTHCardinal Health 200, LLCKNT2025-12-19
08015262035662NUTRIFITPENTAFERTE ITALIA SRLKNT2025-07-03
10192253011128KangarooCardinal Health 200, LLCKNT2025-05-28
10192253011159CARDINAL HEALTHCardinal Health 200, LLCKNT2025-04-03
10192253011173CARDINAL HEALTHCardinal Health 200, LLCKNT2025-04-03
10192253011197CARDINAL HEALTHCardinal Health 200, LLCKNT2025-04-03
10192253011227CARDINAL HEALTHCardinal Health 200, LLCKNT2025-04-03
10192253011258CARDINAL HEALTHCardinal Health 200, LLCKNT2025-04-03
10192253011272CARDINAL HEALTHCardinal Health 200, LLCKNT2025-04-03
10192253011296CARDINAL HEALTHCardinal Health 200, LLCKNT2025-04-03
10192253011104KangarooCardinal Health 200, LLCKNT2025-01-14
G461EGCT36M0EndolumikEndolumik, Inc.KNT2024-08-06
G461EGCT40M0EndolumikEndolumik, Inc.KNT2024-08-06
10192253011319KangarooCardinal Health 200, LLCKNT2024-06-13
10192253011326KangarooCardinal Health 200, LLCKNT2024-06-13