FDA.reportPublic FDA data

VueBlu

Primary DI
05391530190527
Brand
VueBlu
Company
COSMO SPA
Model
5000311
Device description
Individual 10mL Vial of Methylene Blue Solution 0.5%
Published
2023-07-21
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
NBGMarker, Colon

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NBGMarker, ColonGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05391530190541PackageGS15In Commercial Distribution
05391530190558PackageGS196In Commercial Distribution
05391530190527PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05391530190541053915301905415391530190541
05391530190558053915301905585391530190558
05391530190527053915301905275391530190527

GMDN Terms#

Term, Definition table
TermDefinition
Operative procedure tissue/fluid stainA solution (e.g., methylene blue, amylase-degraded microspheres) intended to be used as an in vivo tissue- or fluid-staining visualization aid during and/or after open or minimally-invasive surgery, particularly for delineation of tissues and operative pieces, seal testing sutures, and/or detection of leaks (e.g., pancreatic juice) and fistulas. Exact usage depends on the requirements of the surgeon and the surgical procedure performed. It is typically supplied in a glass vial or syringe. After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume10Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature20 Degrees Celsius25 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
1-866-468-5157Info@CosmoTechnologies.com

Regulatory Flags#

DUNS number
630431955
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05391530190541VueBlu50003112023-07-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
46932503562711EndoINK(TM) Endoscopic MarkerMicro-Tech (Nanjing) Co., Ltd.NBG2023-07-31
46932503562728EndoINK(TM) Endoscopic MarkerMicro-Tech (Nanjing) Co., Ltd.NBG2023-07-31
06932503562713EndoINK(TM) Endoscopic MarkerMicro-Tech (Nanjing) Co., Ltd.NBG2023-07-31
06932503562720EndoINK(TM) Endoscopic MarkerMicro-Tech (Nanjing) Co., Ltd.NBG2023-07-31
16932503562710MTMicro-Tech (Nanjing) Co., Ltd.NBG2023-07-31
16932503562727MTMicro-Tech (Nanjing) Co., Ltd.NBG2023-07-31
56932503562718MTMicro-Tech (Nanjing) Co., Ltd.NBG2023-07-31
56932503562725MTMicro-Tech (Nanjing) Co., Ltd.NBG2023-07-31
05391530190541VueBluCOSMO SPANBG2023-07-21
16932503562864MTMicro-Tech (Nanjing) Co., Ltd.NBG2023-06-28
16932503562871STA-BIL(TM) Non-migrating Endoscopic InkMicro-Tech (Nanjing) Co., Ltd.NBG2023-06-28
06932503562010Blue Beacon(TM) GI MarkerMicro-Tech (Nanjing) Co., Ltd.NBG2023-06-28
06932503562027Blue Beacon(TM) GI MarkerMicro-Tech (Nanjing) Co., Ltd.NBG2023-06-28
06932503562058MTMicro-Tech (Nanjing) Co., Ltd.NBG2023-06-28
06932503562065Blue Beacon(TM) GI MarkerMicro-Tech (Nanjing) Co., Ltd.NBG2023-06-28
16932503562017MTMicro-Tech (Nanjing) Co., Ltd.NBG2023-06-28
16932503562024MTMicro-Tech (Nanjing) Co., Ltd.NBG2023-06-28
16932503562055MTMicro-Tech (Nanjing) Co., Ltd.NBG2023-06-28
16932503562062MTMicro-Tech (Nanjing) Co., Ltd.NBG2023-06-28
26932503562861MTMicro-Tech (Nanjing) Co., Ltd.NBG2023-06-28
26932503562878MTMicro-Tech (Nanjing) Co., Ltd.NBG2023-06-28
00724995216528NAUS EndoscopyNBG2022-01-28
10724995216525NAUS EndoscopyNBG2022-01-28
08809380059002Black EyeTHE STANDARD CO.,LTD.NBG2019-01-18
00893029002106Spot Ex Endoscopic TattooGI Supply, Inc.NBG2017-12-26
10893029002103Spot Ex Endoscopic TattooGI Supply, Inc.NBG2017-12-26
08809539692555Pointer Endoscopic MarkerOSTEONIC CO.,Ltd.NBG2017-05-12
00893029002069SPOT Endosopic MarkerGI Supply, Inc.NBG2016-09-24
00893029002441SPOT Endosopic MarkerGI Supply, Inc.NBG2016-09-24