FDA.reportPublic FDA data

NeoMed Urinary Drainage Catheter

Primary DI
20817584010912
Brand
NeoMed Urinary Drainage Catheter
Company
NEOMED, INC.
Model
UC5.0
Catalog number
UC5.0
Device description
Silicone Urinary Drainage Catheter, 5.0 Fr
Published
2016-09-19
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
GBMCatheter, Urethral

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GBMCatheter, UrethralGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10817584010915PackageGS110In Commercial Distribution
20817584010912PackageGS116In Commercial Distribution
00817584010918PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081758401091510817584010915
2081758401091220817584010912
00817584010918008175840109188175840109180817584010918

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
886-876-2225info@neomedinc.com

Regulatory Flags#

DUNS number
799772079
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
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10817584013336NeoDrapeNDND2020-05-19
20817584013371Fenestrated NeoDrapeND-FSND-FS2020-05-19
00817584013384NeoConnect Press-in Bottle AdapterPI-ENCPI-ENC2020-09-22
10817584013404NeoConnect Press-in Bottle AdapterPI-DNCPI-DNC2020-09-22
20817584013203NeoConnect Oral / Enteral Syringe, OTCNeo3Neo32019-09-06
20817584013210NeoConnect Oral / Enteral Syringe, OTCNeo6Neo62019-09-06
20817584013227NeoConnect Oral / Enteral Syringe, OTCNeo12Neo122019-09-06
10817584013237NeoConnect Oral / Enteral Syringe, OTCNeo60Neo602019-09-06
20817584010615NeoMed Oral SyringeBC-S05EOBC-S05EO2016-09-19
20817584010622NeoMed Oral SyringeBC-S1EOBC-S1EO2016-09-19
20817584010639NeoMed Oral SyringeBC-S3EOBC-S3EO2016-09-19
20817584010646NeoMed Oral SyringeBC-S6EOBC-S6EO2016-09-19
20817584010653NeoMed Oral SyringeBC-S12EOBC-S12EO2016-09-19
20817584010660NeoMed Oral SyringeBC-S20EOBC-S20EO2016-09-19
20817584010677NeoMed Oral SyringeBC-S35EOBC-S35EO2016-09-19
20817584010684NeoMed Oral SyringeBC-S60EOBC-S60EO2016-09-19
20817584010691NeoMed Oral SyringeBA-S05EOBA-S05EO2016-09-19
20817584010707NeoMed Oral SyringeBA-S1EOBA-S1EO2016-09-19
20817584010714NeoMed Oral SyringeBA-S3EOBA-S3EO2016-09-19
20817584010721NeoMed Oral SyringeBA-S6EOBA-S6EO2016-09-19

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