FDA.reportPublic FDA data

Venoscope

Primary DI
B853NT010
Brand
Venoscope
Company
VENOSCOPE, LLC
Model
NT01
Catalog number
NT01
Device description
Handheld battery operated transilluminator used for locating veins for IV therapy and blood draws in small neonate patients.
Published
2020-03-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HJNTransilluminator, Battery-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HJNTransilluminator, Battery-PoweredOphthalmic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K941035000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K941035000VENOSCOPETrinity Partners, LLC1994-05-16HJN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B853NT010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Skin transilluminator, battery-poweredA hand-held, battery-powered device with a built-in light source, usually together with a lens, intended to be used to illuminate the skin and soft tissues, rendering them translucent for examination. It is typically used to examine subcutaneous and scrotal tissue/contents for lesions, and veins (e.g., on the scalp of an infant) for anatomical abnormalities. This device may also be known as a diaphanoscope, a phaneroscope or a light scanner.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length4.5Inch
Width2.25Inch

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-284-7655info@venoscope.com

Regulatory Flags#

DUNS number
612726596
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B853VT030VenoscopeVT03VT032020-03-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06945095543787zumaxZumax Medical Co., LTDHJN2026-05-21
06945095544050zumaxZumax Medical Co., LTDHJN2026-05-21
06945095544678zumaxZumax Medical Co., LTDHJN2026-05-21
06945095544692zumaxZumax Medical Co., LTDHJN2026-05-21
B945BERAI0BernellBernellHJN2026-05-02
B945MTBIFL0BernellBernellHJN2026-05-02
B945MTBIH20BernellBernellHJN2026-05-02
00697077003166Amico Diagnostic IlluminatorAmico Diagnostic IncorporatedHJN2026-02-24
00697077003173Amico Diagnostic IlluminatorAmico Diagnostic IncorporatedHJN2026-02-24
04053755202973FINOFF TRANSILLUMINATORHeine Optotechnik GmbH & Co. KGHJN2025-07-17
00850064466348VF1000LED Vein locatorFABINJECT LLCHJN2025-03-02
00850038195564EZ-TRI-3600U.S. OPHTHALMIC, L.L.C.HJN2025-02-19
07898915128789VF1000LED Vein locatorFABINJECT INDUSTRIA E COMERCIO IMPORTACAO E EXPORTACAO LTDAHJN2024-06-07
00732094074130Welch Allyn, Inc.WELCH ALLYN, INC.HJN2023-08-17
00732094074185Welch Allyn, Inc.WELCH ALLYN, INC.HJN2023-08-17
00732094074192Welch Allyn, Inc.WELCH ALLYN, INC.HJN2023-08-17
00732094082708Welch Allyn, Inc.WELCH ALLYN, INC.HJN2023-08-17
00732094082715Welch Allyn, Inc.WELCH ALLYN, INC.HJN2023-08-17
00732094082739Welch Allyn, Inc.WELCH ALLYN, INC.HJN2023-08-17
04260114140214ASTODIAStihler Electronic GmbHHJN2023-07-18
00850018561099Wee Sight Transilluminator INTERNATIONAL BIOMEDICAL, LTD.HJN2023-06-20
00732094084207Welch Allyn, Inc.WELCH ALLYN, INC.HJN2023-04-25
04053755119943OPHTHALMIC EXAMINATION LAMPHeine Optotechnik GmbH & Co. KGHJN2022-12-21
04053755120109OPHTHALMIC EXAMINATION LAMPHeine Optotechnik GmbH & Co. KGHJN2022-12-21
04053755200429FINOFF TRANSILLUMINATORHeine Optotechnik GmbH & Co. KGHJN2022-12-21
00732094082722Welch Allyn, Inc.WELCH ALLYN, INC.HJN2021-07-12
10812594013000NeoGlo DisposableNeotech Products LLCHJN2021-05-20
10812594013062NeoGlo DisposableNeotech Products LLCHJN2021-05-20
00812594012716NeoGlo®Neotech Products LLCHJN2021-05-20
00812594013003NeoGlo DisposableNEOTECH PRODUCTS, INC.HJN2021-05-20