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BOEHRINGER LABORATORIES, LLC

Last updated September 17, 2026

Information

Country: US
Address: 300 Thoms Drive, Phoenixville, PA, 19460
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EUDAMED SRN: —
FDA FEI Number: 2518417
DUNS Number: —

Catalogue (157)

Page 3 of 4

Device	Model / Reference	Registries	Class	Status
BOEHRINGER® ViSiGi Lux 36 Fr	5336SB	FDA UDI	Class II	Active
BOEHRINGER® CareDry™ System	7665	FDA UDI	Class I	Active
BOEHRINGER® Lens Cap for 3800 Series, Colored Blush Pink	9070	FDA UDI	Class II	Active
BOEHRINGER® Regulator Vertical Mount With Power Take Off	9061	FDA UDI	Class II	Unknown
BOEHRINGER® SUPPLY LINE-VAVD-DISS (20' length)	3943	FDA UDI	Class II	Unknown
BOEHRINGER® DISS Hand-Tight Nut and Gland Adapter	1504	FDA UDI	Class II	Active
BOEHRINGER® ViSiGi 3D™ Sleeve Gastrectomy Calibration System, size 36Fr w/bulb	5236B	FDA UDI	Class II	Active
BOEHRINGER® CareDry™ Regulator PST	7630	FDA UDI	Class II	Unknown
BOEHRINGER® Suction Regulator, Pediatric Intermittent/Continuous, 0-100, off/con	3814	FDA UDI	Class II	Active
BOEHRINGER® ViSiGi 3D™ Low Suction Sleeve Gastrectomy Calibration Sys, size 40Fr	5240LS	FDA UDI	Class II	Unknown
BOEHRINGER® Suction Regulator, Continuous, 0-200, off/reg/line	3800	FDA UDI	Class II	Active
BOEHRINGER® 1/8" x 1/8" Pipe Fitting	2164	FDA UDI	Class II	Active
BOEHRINGER® Continuous Suction Regulator, 0-760, off/reg/line	3840	FDA UDI	Class II	Active
BOEHRINGER® Suction Flowmeter Vacuum Assisted Venous Drainage Controller	3930	FDA UDI	Class II	Active
ViSiGi LUX (5332); ViSiGi LUX (5336); ViSiGi LUX (5340)	K234033	FDA 510(k)	Class II	Active
Autovac Closed Wound Suction System	K930615	FDA 510(k)	Class I	Active
Boehringer Laboratories Suction Intermittor	K853095	FDA 510(k)	Class II	Active
Autovac Orthopedic Autotransfusion System	K014187	FDA 510(k)	Class II	Active
Auto-Vac Intraoperative Autotrans. Reservoir #7904	K881129	FDA 510(k)	Class II	Active
Tissue Removal Pouch	K150781	FDA 510(k)	Class II	Active
Resuscitation Valve	K832868	FDA 510(k)	Class II	Active
Filtered Vacuum Safety Trap Bottle	K855074	FDA 510(k)	Class II	Active
Nicotinamide-Adenine Ainucleotide (nad)	K790248	FDA 510(k)	Class II	Active
Boehringer Laboratories Liver Retractor	K243399	FDA 510(k)	Class II	Active
Autovac Bp Syste, 2000 Series	K955010	FDA 510(k)	Class II	Active
Positive Displacement Spirometer	K760971	FDA 510(k)	Class II	Active
Co 2 Meter	K792155	FDA 510(k)	Class II	Active
ViSiGi 3D Gastric Sizing Tube	K234145	FDA 510(k)	Class II	Active
Oscillating Bone Saw Blade, 6200 Series	K934390	FDA 510(k)	Class I	Active
Bronchodilator Tee - 9056 Series	K873521	FDA 510(k)	Class II	Active
Fluid Cooled Bone Saw Blade, 6000 Series	K924953	FDA 510(k)	Class I	Active
Boehringer Laboratories Suction Pump System	K061788	FDA 510(k)	Class II	Active
Autovac (r) Autotransfusion System, 7900 Modified	K904164	FDA 510(k)	Class II	Active
T-Vac Pleural Drainage Unit, 7800 Series	K861025	FDA 510(k)	Class II	Active
Autowand(tm) 7xxx Series	K902059	FDA 510(k)	Class II	Active
Portable Monitoring & Screening Spirom.	K822689	FDA 510(k)	Class II	Active
Boehringer Lab Suction Interrupter	K853155	FDA 510(k)	Class II	Active
Boehringer Mri Suction Regulatory	K013976	FDA 510(k)	Class II	Active
Tissue Removal System	K151990	FDA 510(k)	Class II	Active
Auto-Vac (tm) Autotransfusion Reserv, Model 7900	K862684	FDA 510(k)	Class II	Active
Autovac Closed Wound Autotransfusion System, 7920 S	K932093	FDA 510(k)	Class II	Active
Boehringer Gastric Sizing Tube	K130483	FDA 510(k)	Class II	Active
Boehringer Laboratories Pneumatic Ambulatory Compression System 8200 Series	K020538	FDA 510(k)	Class II	Active
Suction Regulator 7700 Series	K850200	FDA 510(k)	Class II	Active
Boehringer Laboratories Suction Pump System	K060277	FDA 510(k)	Class II	Active
Autovac(r) Autotransfusion System, 7900 Series	K901138	FDA 510(k)	Class II	Active
Autovac 7900 Series	K924894	FDA 510(k)	Class II	Active
Boehringer Autovac(r) 7900 Series	K945775	FDA 510(k)	Class II	Active
Boehringer Laboratories Suction Regulator, Modified	K933232	FDA 510(k)	Class II	Active
Spirometer, Mini Positive	K782145	FDA 510(k)	Class II	Active

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FDA Recalls (6)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Aug 1, 2005	Z-0157-06	—	terminated	Condition exists that prevents complete shutoff of the valve
Aug 1, 2005	Z-0156-06	—	terminated	Condition exists that prevents complete shutoff of the valve
Aug 1, 2005	Z-0155-06	—	terminated	Condition exists that prevents complete shutoff of the valve
May 19, 2004	Z-1232-04	—	terminated	The suction regulator incorporates a gauge for the verification of suction levels. The particular lot of gauges used in the production of the regulators exhibits a potential to develop a leak and cause the delivered suction to be inaccurate.
May 19, 2004	Z-1231-04	—	terminated	The suction regulator incorporates a gauge for the verification of suction levels. The particular lot of gauges used in the production of the regulators exhibits a potential to develop a leak and cause the delivered suction to be inaccurate.
Nov 7, 2003	Z-0227-04	—	terminated	Inadequate bond where the tube attaches to the inlet of the bulb.