FDA.reportPublic FDA data

BOEHRINGER® ViSiGi Lux 36 Fr

Primary DI
30816286021124
Brand
BOEHRINGER® ViSiGi Lux 36 Fr
Company
BOEHRINGER LABORATORIES, LLC
Model
5336SB
Device description
ViSiGi Lux 36Fr
Published
2025-05-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KNTTubes, Gastrointestinal (And Accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNTTubes, Gastrointestinal (And Accessories)Gastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30816286021124PackageGS13In Commercial Distribution
10816286021120PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3081628602112430816286021124
1081628602112010816286021120

GMDN Terms#

Term, Definition table
TermDefinition
Gastric calibration tubeA thin, flexible, hollow cylinder with an inflatable balloon at the distal end designed to be inserted into a patient's stomach through the mouth and oesophagus to create and size a gastric pouch typically for a bariatric gastric surgical procedure (e.g., sleeve gastrectomy, gastric banding). The proximal end may include a check valve and connects to a syringe, typically included, intended to inflate the balloon to a predetermined volume; fluid suction/irrigation ports are provided at the distal end. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge36French

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
610-278-0900info@boehringerlabs.com

Regulatory Flags#

DUNS number
079991657
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10816286021199Boehringer Venturi Oxygen Valve Inlet39602026-09-22
10816286021182Boehringer Surgical Suction Device50302025-11-24
20816286021189Boehringer Surgical Suction Device50302025-11-24
10816286021175UpLivt 52002025-07-16
70816286021177UpLivt 52002025-07-16
10816286021120BOEHRINGER® ViSiGi Lux 36 Fr5336SB2025-05-20
10816286021137BOEHRINGER® ViSiGi Lux 40 Fr5340SB2025-05-20
30816286021131BOEHRINGER® ViSiGi Lux 40 Fr5340SB2025-05-20
10816286021151BOEHRINGER® CareDry™ Male System76802024-12-31
20816286021158BOEHRINGER® CareDry™ Male System76802024-12-31
10816286021168BOEHRINGER® Offset Mount - Four Inches90612024-12-31
10816286021076BOEHRINGER® CareDry™ System76602021-11-01
10816286020659BOEHRINGER® Accessory Bulb for ViSiGi 3D™ Sleeve Gastrectomy Calibration System52502016-08-01
10816286021083TruLim Length Indicating Device501050102022-06-21
10816286020932BOEHRINGER® Smoke Removal System57002020-02-01
10816286020079BOEHRINGER® Care 4™ Suction Regulator, Intermittent/Continuous, 0-200, off/ cont384438442016-08-01
10816286021144BOEHRINGER® CareDry™ System76652023-12-29
20816286021141BOEHRINGER® CareDry™ System76652023-12-29
10816286020949BOEHRINGER® CareDry™ Regulator PST763076302020-01-15
10816286021014BOEHRINGER® Disposable Regulator 100-150mmHg765076502020-04-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00350770997780MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 20 Fr, OTWAvanos Medical, Inc.KNT2026-10-20
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00350770997841MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 20 Fr, PULLAvanos Medical, Inc.KNT2026-10-20
00350770997858MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 24 Fr, PULLAvanos Medical, Inc.KNT2026-10-20
00350770997896MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 14 Fr, PULLAvanos Medical, Inc.KNT2026-10-20
00350770997902MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 20 Fr, PULLAvanos Medical, Inc.KNT2026-10-20
00350770997919MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 24 Fr, PULLAvanos Medical, Inc.KNT2026-10-20
00350770997964MIC* Percutaneous Endoscopic Gastrostomy (PEG) Kit, 20 Fr, PULLAvanos Medical, Inc.KNT2026-10-20
00350770997971MIC* Percutaneous Endoscopic Gastrostomy (PEG) Kit, 20 Fr, PULLAvanos Medical, Inc.KNT2026-10-20
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