FDA.reportPublic FDA data

BOEHRINGER® Cell Salvage Regulator, off/reg/line

Primary DI
10816286020307
Brand
BOEHRINGER® Cell Salvage Regulator, off/reg/line
Company
BOEHRINGER LABORATORIES, LLC
Model
3950
Catalog number
3950
Device description
Cell Salvage Regulator, off/reg/line
Published
2016-08-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KDPRegulator, Vacuum

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KDPRegulator, VacuumGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10816286020307PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081628602030710816286020307

GMDN Terms#

Term, Definition table
TermDefinition
Vacuum suction regulator/regulation set, general-purposeA noninvasive device/collection of noninvasive devices designed to connect to the terminal unit (wall outlet) of a vacuum pipeline system to control the degree of negative pressure during the evacuation of fluids, mucus, or solids during a range of clinical applications (e.g., not dedicated to thoracic suction). It allows continuous and/or intermittent suction at variable levels, incorporates a manometer and controls for monitoring/adjusting the level of suction, and may include collection containers, tubing or a stand/mount; it does not include patient contact devices (e.g., handpiece/tip, catheter).

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
079991657
Device count
1
Premarket exempt
true
Lot or batch
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
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
10197344142460MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-09
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10197344142491MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-09
10197344142507MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-09
10197344142514MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-09
10197344142521MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-09
10197344143306MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-09
10197344143313MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-09
10197344143320MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-09
10197344143337MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-09
10197344143344MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-09
10197344143351MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-09
10197344143368MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-09
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10197344143733MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-09
10197344143740MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-09
10197344143764MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-09
10197344143771MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-09
10197344144433MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-09
10197344144440MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-09
10197344144457MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-09
10197344144464MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-09
10197344144471MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-09
10197344144488MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-09
10197344144495MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-09
10197344144549MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-09
10197344146284MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-09
10197344146291MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-09
10197344146307MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-09