FDA.reportPublic FDA data

RUSCH

Primary DI
44026704306204
Brand
RUSCH
Company
TELEFLEX INCORPORATED
Model
IPN052734
Catalog number
564000
Device description
Word Catheter, Sterile
Published
2018-09-15
Public version status
Update
Distribution status
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
GBACATHETER, BALLOON TYPE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GBACatheter, Balloon TypeGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
24026704306200PackageGS16In Commercial Distribution
44026704306204PackageGS180In Commercial Distribution
04026704306206PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2402670430620024026704306200
4402670430620444026704306204
04026704306206040267043062064026704306206

GMDN Terms#

Term, Definition table
TermDefinition
Single-administration urethral drainage catheterA sterile, flexible tube intended to be inserted one-time through the urethra to the urinary bladder, by the patient/user or a healthcare provider, to provide urine drainage, typically for an individual who is physiologically incapable of voiding. It is typically made of polyvinyl chloride (PVC), and may be coated with a lubricating substance (e.g., acquires a smooth and mucous surface when brought in contact with water). The distal end can have various tip designs [e.g., open-ended, rounded with a side hole(s)], and the proximal end typically connects to a urine collection container. 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
true
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
00801902002266ARROWIPN000082AI-071342016-09-16
00801902003362ARROWIPN035388CC-017002026-08-03
00850921007417ARROWIPN919634DLX-200-USC2026-08-03
04026704916955RUSCHIPN9007315640002026-08-03
04026704934812TELEFLEXIPN931133ST192026-08-03
05060112310058LMA AIRWAY MANAGEMENTIPN9016471000152026-08-03
05060112310065LMA AIRWAY MANAGEMENTIPN9016491000202026-08-03
05060112310607LMA AIRWAY MANAGEMENTIPN9018611500152026-08-03
10801902170191ARROWIPN917307CS-017012026-08-03
10801902206241ARROWIPN922981PW-18080-HS2026-08-03
10801902215168ARROWIPN9280309001T-VC-0052026-08-03
10801902219210ARROWIPN929382CV-15123-F2026-08-03
10801902226416ARROWIPNB00521ASK-21242-UR32026-08-03
14026704730466PILLINGIPN924356P358PRA2026-08-03
14026704934758LMA AIRWAY MANAGEMENTIPN9292541360652026-08-03
14026704934765LMA AIRWAY MANAGEMENTIPN9292561360752026-08-03
14026704934772LMA AIRWAY MANAGEMENTIPN9292571360802026-08-03
14026704934802LMA AIRWAY MANAGEMENTIPN9292551360702026-08-03
00801902004857ARROWIPN033843AK-040202016-09-16
05060112310041LMA AIRWAY MANAGEMENTIPN9016451000102026-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04026704916955RUSCHTELEFLEX INCORPORATEDGBA2026-08-03
00860014541704EnvisionSPINAL STABILIZATION TECHNOLOGIES LIMITEDGBA2026-04-30
00860014541711EnvisionSPINAL STABILIZATION TECHNOLOGIES LIMITEDGBA2026-04-30
06979032640031GOBENHUZHOU JUNDA INDUSTRY CO., LTD.GBA2025-08-26
M7403150006VerifySPINEOLOGY INC.GBA2023-06-26
00887482173718Symmetry Surgical®ASPEN SURGICAL PRODUCTS, INC.GBA2022-09-21
00678467004963 Mui Scientific H & A Mui Enterprises IncGBA2019-10-17
00678467005007 Mui Scientific H & A Mui Enterprises IncGBA2019-10-17
00678467005847 Mui Scientific H & A Mui Enterprises IncGBA2019-10-17
00678467005915 Mui Scientific H & A Mui Enterprises IncGBA2019-10-17
00678467006134 Mui Scientific H & A Mui Enterprises IncGBA2019-10-17
00678467006547 Mui Scientific H & A Mui Enterprises IncGBA2019-10-17
00678467006677 Mui Scientific H & A Mui Enterprises IncGBA2019-10-17
00678467006707 Mui Scientific H & A Mui Enterprises IncGBA2019-10-17
00678467006868 Mui Scientific H & A Mui Enterprises IncGBA2019-10-17
00678467506184 Mui Scientific H & A Mui Enterprises IncGBA2019-10-17
00678467506252 Mui Scientific H & A Mui Enterprises IncGBA2019-10-17
00678467506276 Mui Scientific H & A Mui Enterprises IncGBA2019-10-17
00678467506337 Mui Scientific H & A Mui Enterprises IncGBA2019-10-17
00678467506610 Mui Scientific H & A Mui Enterprises IncGBA2019-10-17
00678467001450Mui ScientificH & A Mui Enterprises IncGBA2019-10-16
00678467001627 Mui Scientific H & A Mui Enterprises IncGBA2019-10-16
00678467001894 Mui Scientific H & A Mui Enterprises IncGBA2019-10-16
00678467001924 Mui Scientific H & A Mui Enterprises IncGBA2019-10-16
00678467002150 Mui Scientific H & A Mui Enterprises IncGBA2019-10-16
00678467002358 Mui Scientific H & A Mui Enterprises IncGBA2019-10-16
00678467002426 Mui Scientific H & A Mui Enterprises IncGBA2019-10-16
00678467002549 Mui Scientific H & A Mui Enterprises IncGBA2019-10-16
00678467002600 Mui Scientific H & A Mui Enterprises IncGBA2019-10-16
00678467002655 Mui Scientific H & A Mui Enterprises IncGBA2019-10-16