Pop-On Male External Catheter

Primary DI
20801741070536
Brand
Pop-On Male External Catheter
Company
C. R. Bard, Inc.
Model
32301HP
Catalog number
32301HP
Device description
Pop-On Self-Adhering Male External Catheter
Published
2020-09-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
NNXDEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE

Product Code Classifications

CodeDeviceSpecialtyClass
NNXDevice, Incontinence, Urosheath Type, Non-SterileGastroenterology, Urology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10801741070539PackageGS130In Commercial Distribution
20801741070536PackageGS1300In Commercial Distribution
00801741070532PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1080174107053910801741070539
2080174107053620801741070536
00801741070532008017410705328017410705320801741070532

GMDN Terms

TermDefinition
Urinary incontinence penis sheath/port, single-use, non-sterileA non-sterile device intended to be worn on or over the penis by an incontinent patient to channel urine from the penis, via a tube, into a collection bag. It consists of a penis-worn sheath (e.g., condom-catheter) or adhesive port (e.g., glans penis attachment), and may include a portion of tubing; the bag is not included. This device provides an alternative to inserting a catheter through the urethra, especially when difficulty is encountered in insertion or retention. It may be used to treat urinary incontinence or for non-ambulatory patients. This is a single-use device.

Device Sizes

TypeValueUnit
Outer Diameter25Millimeter

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)526-4455medical.services@crbard.com

Regulatory Flags

DUNS number
016898496
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
false
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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10801741122030Bard® Robinson Catheter003726000372602016-07-23
10801741122047Bard® Robinson Catheter003728000372802016-07-23
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10801741122092Bard® Robinson Catheter003736000373602016-07-23
10801741122108Bard® Robinson Catheter003738000373802016-07-23
10801741122115Bard® Robinson Catheter003740000374002016-07-23
10801741122122Bard® Robinson Catheter003742000374202016-07-23
10801741122139Bard® Robinson Catheter003744000374402016-07-23
10801741122146Bard® Robinson Catheter003746000374602016-07-23
10801741122153Bard® Robinson Catheter003748000374802016-07-23

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