FDA.reportPublic FDA data

BD Intermittent

Primary DI
16948796203995
Brand
BD Intermittent
Company
Hangzhou Bever Medical Devices Co., Ltd.
Model
RTU14C
Catalog number
RTU14C
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
OTC
false
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
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
16948796203995PackageGS130In Commercial Distribution
26948796203992PackageGS1270In Commercial Distribution
06948796203998PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1694879620399516948796203995
2694879620399226948796203992
06948796203998069487962039986948796203998

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 Gauge14French
Catheter Length16Inch

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
528185295
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
false
Sterilization required before use
false

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
16948796204008BD IntermittentRTU16CRTU16C2021-01-23
16948796204015BD IntermittentRTU06PRTU06P2021-01-23
16948796204022BD IntermittentRTU08PRTU08P2021-01-23
16948796204039BD IntermittentRTU10PRTU10P2021-01-23

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