FDA.reportPublic FDA data

REDPINE

Primary DI
06972520301209
Brand
REDPINE
Company
Guangzhou Red Pine Medical Instrument Co., Ltd.
Model
RP-IPD-V2000D
Published
2024-09-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FDFColonoscope And Accessories, Flexible/Rigid
FDSGastroscope And Accessories, Flexible/Rigid
FETEndoscopic Video Imaging System/Component, Gastroenterology-Urology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FDFColonoscope And Accessories, Flexible/RigidGastroenterology, Urology2
FDSGastroscope And Accessories, Flexible/RigidGastroenterology, Urology2
FETEndoscopic Video Imaging System/Component, Gastroenterology-UrologyGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232043000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232043000Endoscopic Video Image Processor (RP-IPD-V2000A, RP-IPD-V2000B, RP-IPD-V2000C, RP-IPD-V2000D), Single-Use Video Gastroscope (RP-GI-G02A, RP-GI-G02B), Single-Use Video Colonoscope (RP-GI-C02A, RP-GI-C02B)Guangzhou Red Pine Medical Instrument Co., Ltd.2024-02-16FDF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06972520301209PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06972520301209069725203012096972520301209

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic video image display unitAn electrically-powered visual display unit (VDU), commonly known as a screen or a monitor, designed to be used exclusively in conjunction with a video endoscope to display to the operator the graphical information captured by the endoscope to facilitate its manipulation during the endoscopic procedure; typically difficult and non-difficult intubation procedures to maintain an open airway. It is typically a portable device with a liquid crystal display (LCD) colour screen and a direct electronic signal connection to the endoscope.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
417649868
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06972520300677Endoscopic Video Image ProcessorRP-IPD-V1000F2025-12-31
06972520301001REDPINERP-G-C242024-08-03
06972520301018REDPINERP-G-C01012024-08-03
06972520301216Ascend™ Single-Use Flexible UreteroscopeASUS-86-900R2026-03-17
06972520301223Ascend™ Single-Use Flexible UreteroscopeASUS-86-300R2026-03-17
06972520301230Ascend™ Single-Use Flexible UreteroscopeASUS-86-300S2026-03-17
06972520301247Ascend™ Single-Use Flexible UreteroscopeASUS-86-900S2026-03-17
06972520301254Ascend™ Single-Use Flexible UreteroscopeASUS-86-900R-DC2026-03-17
06972520301261Ascend™ Single-Use Flexible UreteroscopeASUS-86-300R-DC2026-03-17
06972520301278Ascend™ Single-Use Flexible UreteroscopeASUS-86-300S-DC2026-03-17
06972520301285Ascend™ Single-Use Flexible UreteroscopeASUS-86-900S-DC2026-03-17
06972520301759Single-Use Video Flexible UreterorenoscopeRP-U-C03R92025-12-31
06972520301766Single-Use Video Flexible UreterorenoscopeRP-U-C03S92025-12-31
06972520301773Single-Use Video Flexible UreterorenoscopeRP-U-C03R32025-12-31
06972520301780Single-Use Video Flexible UreterorenoscopeRP-U-C03S32025-12-31
06972520302794Ascend™ Single-Use Flexible UreteroscopeASUS-75-900R2025-12-31
06972520302800Ascend™ Single-Use Flexible UreteroscopeASUS-75-900S2025-12-31
06972520302817Ascend™ Single-Use Flexible UreteroscopeASUS-75-300R2025-12-31
06972520302824Ascend™ Single-Use Flexible UreteroscopeASUS-75-300S2025-12-31
06972520302893Ascend™ Single-Use Flexible Cysto-Nephroscope HDASUS-HD-15R-CYS2025-12-31

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