FDA.reportPublic FDA data

RUSCH

Primary DI
24026704031614
Brand
RUSCH
Company
TELEFLEX INCORPORATED
Model
IPN050871
Catalog number
220500-000160
Device description
Bladder catether, cyl. Tip, 2 eyes
Published
2016-09-16
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
EZDCATHETER, STRAIGHT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EZDCatheter, StraightGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
24026704031614PackageGS150In Commercial Distribution
44026704031618PackageGS112In Commercial Distribution
04026704031610PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2402670403161424026704031614
4402670403161844026704031618
04026704031610040267040316104026704031610

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry; Keep away from sunlight

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
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20801902219385ARROWEDC-00622EDC-006222026-03-24
30801902219405ARROWEDC-00820EDC-008202026-03-24
20801902219415ARROWEDC-00822EDC-008222026-03-24
20801902219460ARROWEDC-00818-MEDC-00818-M2026-03-24
20801902219484ARROWEDC-00622-HCEDC-00622-HC2026-03-24
20801902219514ARROWEDC-00822-HCEDC-00822-HC2026-03-24
20801902193418ARROWIPN920120AW-04432-N2026-03-23
30841156103983SUPERCROSS530253022026-03-23
20841156103993SUPERCROSS530353032026-03-23
20841156104006SUPERCROSS530453042026-03-23
20841156104013SUPERCROSS530553052026-03-23
20841156104020SUPERCROSS530653062026-03-23
20841156104037SUPERCROSS530753072026-03-23
20841156104044SUPERCROSS530853082026-03-23
30841156104058SUPERCROSS530953092026-03-23
24026704941494PILLINGP12797P127972026-03-23
24026704941500PILLINGP12805P128052026-03-23
24026704941555PILLINGP13063P130632026-03-23
24026704941562PILLINGP13065P130652026-03-23
24026704941579PILLINGP13081P130812026-03-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
50850058254451EZ-Protect™HR PHARMACEUTICALS INC.EZD2026-02-05
00850058254463EZ-Protect™HR PHARMACEUTICALS INC.EZD2026-02-05
50850058254475EZ-Protect™HR PHARMACEUTICALS INC.EZD2026-02-05
50850058254482EZ-Protect™HR PHARMACEUTICALS INC.EZD2026-02-05
50850058254499EZ-Protect™HR PHARMACEUTICALS INC.EZD2026-02-05
50850058254505EZ-Protect™HR PHARMACEUTICALS INC.EZD2026-02-05
50850058254512EZ-Protect™HR PHARMACEUTICALS INC.EZD2026-02-05
50850058254529EZ-Protect™HR PHARMACEUTICALS INC.EZD2026-02-05
50850058254536EZ-Protect™HR PHARMACEUTICALS INC.EZD2026-02-05
50850058254543EZ-Protect™HR PHARMACEUTICALS INC.EZD2026-02-05
50850058254550EZ-Protect™HR PHARMACEUTICALS INC.EZD2026-02-05
50850058254567EZ-Protect™HR PHARMACEUTICALS INC.EZD2026-02-05
05708932778275SpeediCath Flex SetColoplast A/SEZD2026-02-05
05708932778282SpeediCath Flex SetColoplast A/SEZD2026-02-05
07333387054537LoFric® Origo™Wellspect ABEZD2025-11-24
07333387054575LoFric® Origo™Wellspect ABEZD2025-11-24
07333387054605LoFric® Origo™Wellspect ABEZD2025-11-24
20197344162021MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
20197344162045MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
20197344162052MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
20197344162069MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
20197344162076MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
20197344162113MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
20197344162120MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
20197344162137MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
20197344162144MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
20197344162151MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
20197344162168MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
20197344162182MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
20197344162199MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22