FDA.reportPublic FDA data

BD Intermittent

Primary DI
06948796203929
Brand
BD Intermittent
Company
Hangzhou Bever Medical Devices Co., Ltd.
Model
BUC10F
Catalog number
BUC10F
Device description
BD Intermittent Catheter
Published
2020-12-08
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
GBMCatheter, Urethral

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K111405000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111405000BEVER UNOCATED / COATED, PAEDIATRIC / MALE / FEMALE NELATON-TIP / TIEMANN-TIP INTERMITTENT CATHETER,Hangzhou Bever Medical Devices Co., Ltd.2012-02-13GBM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16948796203926PackageGS130In Commercial Distribution
26948796203923PackageGS1300In Commercial Distribution
06948796203929PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1694879620392616948796203926
2694879620392326948796203923
06948796203929069487962039296948796203929

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 Gauge10French
Catheter Length6.3Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Away from Sunlight and Keep Dry.

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
06948796204018BD IntermittentRTU06PRTU06P2021-01-23
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

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