FDA.reportPublic FDA data

BOEHRINGER® Accessory Bulb for ViSiGi 3D™ Sleeve Gastrectomy Calibration System

Primary DI
10816286020659
Brand
BOEHRINGER® Accessory Bulb for ViSiGi 3D™ Sleeve Gastrectomy Calibration System
Company
BOEHRINGER LABORATORIES, LLC
Model
5250
Device description
Accessory Bulb for ViSiGi 3D™ Sleeve Gastrectomy Calibration System
Published
2016-08-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K130483000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130483000BOEHRINGER GASTRIC SIZING TUBEBoehringer Laboratories, LLC2013-03-28KNT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30816286020653PackageGS15In Commercial Distribution
50816286020657PackageGS125In Commercial Distribution
10816286020659PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3081628602065330816286020653
5081628602065750816286020657
1081628602065910816286020659

GMDN Terms#

Term, Definition table
TermDefinition
General positive-pressure manual hand inflatorA hand-operated manual device designed to draw in ambient air and expel the air from a connected nozzle to inflate a device (e.g., mattress, patient head support rings); it is not intended to be used with invasive devices. It is typically designed as a bicycle pump, a stirrup pump, or a large syringe-like pump, and is designed for use in the home and healthcare facilities. This is a reusable device.

Contacts#

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

Regulatory Flags#

DUNS number
079991657
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
30816286021124BOEHRINGER® ViSiGi Lux 36 Fr5336SB2025-05-20
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
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
10816286021038BOEHRINGER® CareDry™ Wand764076402021-01-01

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