FDA.reportPublic FDA data

VueBlu

Primary DI
05391530190541
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
OTC
false
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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
630431955
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05391530190527VueBlu50003112023-07-21

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
05391530190527VueBluCOSMO 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