FDA.reportPublic FDA data

LUMINELLE Aspirator

Primary DI
00853277008107
Brand
LUMINELLE Aspirator
Company
UVISION 360, INC.
Model
LUM-A
Catalog number
20081
Device description
LUMINELLE Aspirator
Published
2024-02-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
QFZGastroenterology-Urology Accessories To A Biopsy Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QFZGastroenterology-Urology Accessories To A Biopsy InstrumentGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10853277008104PackageGS15In Commercial Distribution
00853277008107PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085327700810410853277008104
00853277008107008532770081078532770081070853277008107

GMDN Terms#

Term, Definition table
TermDefinition
Endocervical aspiratorA collection of devices designed to remove superficial tissue from the mucous membrane lining the cervical canal (endometrium) through manually-powered suction. It typically includes a slender endocervical curette, a syringe, a bulb, and a pipette. The device is used in obstetrics, gynaecology, surgery, oncology, histology, fertility studies, and cancer screening (cervical carcinoma); it is also used after colposcopy and to aid fertility by removing the mucus plug from the cervix.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity0 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Fahrenheit60 Degrees Fahrenheit

Regulatory Flags#

DUNS number
080826327
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10853277008104LUMINELLE AspiratorLUM-A200812024-02-29
00853277008084LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy)LUMBx-360 UP200802021-08-13
00853277008091LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy)LUMBx-360 DOWN200852021-08-13
10853277008081LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy)LUMBx-360 UP200802021-08-13
10853277008098LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy)LUMBx-360 DOWN200852021-08-13
00853277008060LUMINELLE Dx 360o Rotatable Disposable Sheath (Diagnostic)LUMDx-360200702019-11-07
00853277008053LUMINELLE DTx 360 Rigid Rotatable Disposable SheathLUMDTx-360R200602019-06-17
00853277008008LUMINELLE DTx 360 Rotatable Disposable SheathsLUMDTx-360200202019-05-30
00853277008015Uvision HysteroscopeLUMDTx-A1200102019-05-30
00853277008022Uvision Hysteroscope Cable200502019-05-30
00853277008039Luminelle DTx Control Hub200122019-05-30
00853277008046LUMINELLE DTx Hysteroscopy SystemLumDTX-A200302019-05-30
10853277008050LUMINELLE DTx 360 Rigid Rotatable Disposable SheathLUMDTx-360R200602019-06-17
10853227708054LUMINELLE DTx 360 Rigid Rotatable Disposable SheathLUMDTx-360R200602019-06-17
00853227708002LUMINELLE DTx 360 Rotatable Disposable SheathsLUMDTx-360200202019-05-30
00853227708019Uvision HysteroscopeLUMDTx-A1200102019-05-30
00853227708026Uvision Hysteroscope Cable200502019-05-30
00853227708033Luminelle DTx Control Hub200122019-05-30
00853227708040LUMINELLE DTx Hysteroscopy SystemLumDTX-A200302019-05-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840183515317BR Surgical, LLCBR Surgical, LLCQFZ2024-07-22
10853277008104LUMINELLE AspiratorUVISION 360, INC.QFZ2024-02-29