FDA.reportPublic FDA data

URO Saf-Gard Extension Tubing

Primary DI
00868636000401
Brand
URO Saf-Gard Extension Tubing
Company
URO CONCEPTS INC
Model
18 inch
Catalog number
UROET18
Device description
18 “Tubing
Published
2019-08-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KNXCollector, Urine, (And Accessories) For Indwelling Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNXCollector, Urine, (And Accessories) For Indwelling CatheterGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00868636000401PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00868636000401008686360004018686360004010868636000401

GMDN Terms#

Term, Definition table
TermDefinition
Urine monitoring system collectorA sterile receptacle (e.g., a bag) designed to collect a patient's urine as part of a urine monitoring system. It is connected with tubing to the patient's indwelling catheter and is in contact with the system's urine output sensor. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature32 Degrees Fahrenheit120 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-282-6748bruce@avcorhealthy.com

Regulatory Flags#

DUNS number
169168882
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00868636000418URO Saf-Gard Extension Tubing48 inchUROET482019-08-03

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Primary DI, Brand, Company table
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