FDA.report

RUSCH

Primary DI
24026704666113
Brand
RUSCH
Company
TELEFLEX INCORPORATED
Model
IPN029796
Catalog number
390060
Device description
RUSCH DRAIN BAG With Anti-Reflux Valve
Published
2019-06-20
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

Related Records

Contact Domains

Product Codes

CodeName
KNXCOLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER

Product Code Classifications

CodeDeviceSpecialtyClass
KNXCollector, Urine, (And Accessories) For Indwelling CatheterGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
24026704666113PackageGS120In Commercial Distribution
14026704645715PreviousGS10
14026704666116PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2402670466611324026704666113
1402670464571514026704645715
1402670466611614026704666116

GMDN Terms

TermDefinition
Non-wearable urine collection bag, closed-endedA flexible plastic pouch designed to connect to a urinary catheter to collect discharged urine from a patient; it is not designed with an opening for urine drainage. The device is not directly attached to the patient and is disposed of when full. This is a single-use device.

Sterilization Methods

Method

Contacts

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
true
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
true
Sterilization required before use
false

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