FDA.reportPublic FDA data

Glean

Primary DI
00860009800625
Brand
Glean
Company
Bright Uro, Inc
Model
UFM-1000
Catalog number
UFM-1000
Device description
Glean Uroflowmeter
Published
2025-09-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EXQCystometer, Electrical Recording

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EXQCystometer, Electrical RecordingGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860009800625PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860009800625008600098006258600098006250860009800625

GMDN Terms#

Term, Definition table
TermDefinition
Multi-parameter urinary monitoring system control unitAn electrically-powered component of a multi-parameter urinary monitoring system intended to process and display measurements of urinary output, intra-abdominal pressure (via intra-bladder pressure) and core temperature (via intra-bladder temperature). It is a control unit with a monitor connected to a dedicated disposable catheter set (not included) and is typically used in an intensive care setting to manage acute renal failure. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
117955543
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00086000980061GleanGUS-1000-FGUS-1000-F2025-09-23
00860009800601GleanGUS-1000-MGUS-1000-M2025-09-23
00860009800632GleanUFM-1000-CPUFM-1000-CP2025-09-23
00860009800649GleanGUS-1000-MGUS-1000-M2025-09-23
00860009800656GleanGUS-1000-FGUS-1000-F2025-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00890477000395Tri-Electrode Surface EMGSRS Medical Systems, Inc.EXQ2026-03-04
00089047700395Tri-Electrode Surface EMGSRS Medical Systems, Inc.EXQ2026-03-04
00890477000371EMG Elect. w/Lead Wire Set, EP (1 set of 3/bag)SRS Medical Systems, Inc.EXQ2026-01-21
00890477000388EMG Elect. w/Lead Wire Set, EP (1 set of 3/bag)SRS Medical Systems, Inc.EXQ2026-01-21
00086000980061GleanBright Uro, IncEXQ2025-09-23
00860009800601GleanBright Uro, IncEXQ2025-09-23
00860009800632GleanBright Uro, IncEXQ2025-09-23
00860009800649GleanBright Uro, IncEXQ2025-09-23
00860009800656GleanBright Uro, IncEXQ2025-09-23
08032248487123AtmosDELTA MED SPAEXQ2025-09-02
08032248487147AtmosDELTA MED SPAEXQ2025-09-02
08032248487185Infusion SetDELTA MED SPAEXQ2025-09-02
08032248490130AtmosDELTA MED SPAEXQ2025-09-02
38032248487124AtmosDELTA MED SPAEXQ2025-09-02
08032248487130AtmosDELTA MED SPAEXQ2025-09-02
38032248487148AtmosDELTA MED SPAEXQ2025-09-02
38032248487186Infusion SetDELTA MED SPAEXQ2025-09-02
38032248490131AtmosDELTA MED SPAEXQ2025-09-02
E261MMT11730Infusion SetBIOENGINEERING LABORATORIES SRLEXQ2024-12-09
E261MMT11731Infusion SetBIOENGINEERING LABORATORIES SRLEXQ2024-12-09
E261UDA462150AtmosBIOENGINEERING LABORATORIES SRLEXQ2024-10-10
E261UDA462151AtmosBIOENGINEERING LABORATORIES SRLEXQ2024-10-10
08720648846083Flowsensor3-BTMedical Measurement Systems B.V.EXQ2024-09-17
E261UDA582450AtmosBIOENGINEERING LABORATORIES SRLEXQ2024-09-03
E261UDAELN0AtmosBIOENGINEERING LABORATORIES SRLEXQ2024-09-03
E261UDA582451AtmosBIOENGINEERING LABORATORIES SRLEXQ2024-09-03
E261UDAELN1AtmosBIOENGINEERING LABORATORIES SRLEXQ2024-09-03
E261UDA362050AtmosBIOENGINEERING LABORATORIES SRLEXQ2024-09-02
E261UDA362051AtmosBIOENGINEERING LABORATORIES SRLEXQ2024-09-02
18717775955556Flowstar NSMedical Measurement Systems B.V.EXQ2024-05-24