FDA.reportPublic FDA data

BD Intermittent

Primary DI
06948796204018
Brand
BD Intermittent
Company
Hangzhou Bever Medical Devices Co., Ltd.
Model
RTU06P
Catalog number
RTU06P
Device description
BD Ready-To-Use Hydrophilic Catheter
Published
2021-01-23
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

Product Codes#

Code, Name table
CodeName
EZDCatheter, Straight
GBMCatheter, Urethral

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192468000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192468000Male, Nelaton-tip Ready-to-Use Hydrophilic Catheter; Femal, Nelaton-tip Ready-to-Use Hydrophilic Catheter; Pediatric, Nelaton-tip Ready-to-Use Hydrophilic Catheter Intermittent Catheter; Male, Tapered-Tip Tiemann Ready-to-Use Hydrophilic Catheter; Male, Olive-Tip Tiemann Ready-to-Use Hydrophilic CatheterHangzhou Bever Medical Devices Co., Ltd.2019-11-27GBM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16948796204015PackageGS130In Commercial Distribution
26948796204012PackageGS1270In Commercial Distribution
06948796204018PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1694879620401516948796204015
2694879620401226948796204012
06948796204018069487962040186948796204018

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge6French
Catheter Length10Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Away from Sunlight and Keep Dry.
Storage Environment Temperature32 Degrees Fahrenheit140 Degrees Fahrenheit

Regulatory Flags#

DUNS number
528185295
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06948796203950BD IntermittentRTU12MRTU12M2021-01-23
06948796203967BD IntermittentRTU14MRTU14M2021-01-23
06948796203974BD IntermittentRTU16MRTU16M2021-01-23
06948796203981BD IntermittentRTU12CRTU12C2021-01-23
06948796203998BD IntermittentRTU14CRTU14C2021-01-23
06948796204001BD IntermittentRTU16CRTU16C2021-01-23
06948796204025BD IntermittentRTU08PRTU08P2021-01-23
06948796204032BD IntermittentRTU10PRTU10P2021-01-23
06948796204049BD IntermittentRTU10FRTU10F2021-01-23
06948796204056BD IntermittentRTU12FRTU12F2021-01-23
06948796204063BD IntermittentRTU14FRTU14F2021-01-23
16948796203957BD IntermittentRTU12MRTU12M2021-01-23
16948796203964BD IntermittentRTU14MRTU14M2021-01-23
16948796203971BD IntermittentRTU16MRTU16M2021-01-23
16948796203988BD IntermittentRTU12CRTU12C2021-01-23
16948796203995BD IntermittentRTU14CRTU14C2021-01-23
16948796204008BD IntermittentRTU16CRTU16C2021-01-23
16948796204015BD IntermittentRTU06PRTU06P2021-01-23
16948796204022BD IntermittentRTU08PRTU08P2021-01-23
16948796204039BD IntermittentRTU10PRTU10P2021-01-23

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Primary DI, Brand, Company table
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