FDA.report

NeoMed Urinary Drainage Catheter

Primary DI
20817584010929
Brand
NeoMed Urinary Drainage Catheter
Company
NEOMED, INC.
Model
UC6.5
Catalog number
UC6.5
Device description
Silicone Urinary Drainage Catheter, 6.5 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

Related Records

Contact Domains

Product Codes

CodeName
GBMCatheter, Urethral

Product Code Classifications

CodeDeviceSpecialtyClass
GBMCatheter, UrethralGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10817584010922PackageGS110In Commercial Distribution
20817584010929PackageGS116In Commercial Distribution
00817584010925PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1081758401092210817584010922
2081758401092920817584010929
00817584010925008175840109258175840109250817584010925

GMDN Terms

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

Contacts

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

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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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