FDA.reportPublic FDA data

Endoskopiepumpe Senator distributed by KARL STORZ UP030C, 115V

Primary DI
07640108053374
Brand
Endoskopiepumpe Senator distributed by KARL STORZ UP030C, 115V
Company
Ardo medical AG
Model
31.00.22 / UP030C
Catalog number
31.00.22
Published
2025-07-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
BTAPump, Portable, Aspiration (Manual Or Powered)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTAPump, Portable, Aspiration (Manual Or Powered)General, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K011601000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K011601000ARDO SUCTION PUMP MASTER, MODEL 30.00.XX; ARDO SUCTION PUMP SENATOR, MODEL 31.00.XXArdo Medical AG2001-06-08BTA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640108053374PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640108053374076401080533747640108053374

GMDN Terms#

Term, Definition table
TermDefinition
Surgical suction pumpAn electrically-powered device, which may include noninvasive accessories, intended to generate negative pressure for aspiration of body cavities/wounds during a variety of surgical procedures (e.g., general surgery, liposuction, and laparoscopy), typically to facilitate observation; it may also be intended for airway/oral cavity clearance. It is not intended for vascular/thrombectomy use and is not dedicated to thoracic drainage or dental applications; it is not designed for surgical irrigation. The device may incorporate a pressure gauge/controls, and may include collection containers or tubing; it does not include patient contact devices (e.g., handpiece/tip, catheter).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+18444112736customer-service@ardo-usa.com
+41417547070info@ardo.ch

Regulatory Flags#

DUNS number
481670396
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640108055903Breast shell sterile DeTach 12 mm (2 pcs)63.00.48363.00.4832026-07-31
07640108055927Breast shell sterile DeTach 13 mm (2 pcs)63.00.48463.00.4842026-07-31
07640108055941Breast shell sterile DeTach 14 mm (2 pcs)63.00.48563.00.4852026-07-31
07640108055965Breast shell sterile DeTach 15 mm (2 pcs)63.00.48663.00.4862026-07-31
07640108055989Breast shell sterile DeTach 16 mm (2 pcs)63.00.48763.00.4872026-07-31
07640108056009Breast shell sterile DeTach 17 mm (2 pcs)63.00.48863.00.4882026-07-31
07640108055545Breast shell sterile DeTach 18 mm (2 pcs)63.00.47863.00.4782026-07-30
07640108055569Breast shell sterile DeTach 21 mm (2 pcs)63.00.47963.00.4792026-07-30
07640108055583Breast shell sterile DeTach 24 mm (2 pcs)63.00.48063.00.4802026-07-30
07640108054975Ardo Melia63.00.57163.00.5712026-02-27
07640108054982Ardo Melia63.00.57163.00.5712026-02-27
07640108051080Alyssa Hands-Free to-go63.00.51363.00.5132025-09-15
07640108055507Hospital Kit DeTach 21 mm63.00.47663.00.4762025-08-27
07640108055521Hospital Kit DeTach 24 mm63.00.47763.00.4772025-08-27
07640108052506Endoskopiepumpe Master distributed by KARL STORZ UP033C, 115V, mit Fussschalter30.00.22 / UP033C30.00.222025-07-16
07640108055293Endoskopiepumpe Master distributed by KARL STORZ UP034C, 115V30.00.24 / UP034C30.00.242025-07-16
07640108054470Alyssa Hands-Free63.00.45363.00.4532024-01-22
07640108054494Hands-Free Double Pumpset63.00.45463.00.4542024-01-22
00814079020094Amaryll63.00.19063.00.1902022-08-04
00814079020872Double Clinic Pumpset63.00.28363.00.2832016-09-22

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Primary DI, Brand, Company table
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00842429118689MV Flow Aspiration PumpMicrovention, Inc.BTA2026-07-15
06970462546832Suction PumpShenzhen HugeMed Medical Technical Development Co., Ltd.BTA2026-06-04
00860014862731HEYVALUEOak Tech LLCBTA2026-03-27
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10845854041413APEXConmed CorporationBTA2026-03-23
10845854080153CONMEDConmed CorporationBTA2026-03-23
00810149098246R&D Batteries, Inc.R & D Batteries, Inc.BTA2026-02-12
00810149098222R&D Batteries, Inc.R & D Batteries, Inc.BTA2026-01-20
00860014862700GROWNSYOak Tech LLCBTA2026-01-10
00860014862717GROWNSYOak Tech LLCBTA2026-01-10
00860014862724GROWNSYOak Tech LLCBTA2026-01-10
06973222511606Electric Nasal AspiratorShenzhen Desida Technology Co., Ltd.BTA2025-12-31
00810149098178R&D Batteries, Inc.R & D Batteries, Inc.BTA2025-10-27
00860014577550HEYVALUEOak Tech LLCBTA2025-10-13
00860014577567HEYVALUEOak Tech LLCBTA2025-10-13
00860014577574HEYVALUEOak Tech LLCBTA2025-10-13
00860014577581HEYVALUEOak Tech LLCBTA2025-10-13
00860014577505GROWNSYOak Tech LLCBTA2025-08-26
00860014577512GROWNSYOak Tech LLCBTA2025-08-26
00860014577529GROWNSYOak Tech LLCBTA2025-08-26
06953775661706BBLOVEAlicn Medical Shenzhen, Inc.BTA2025-08-04
07640108052506Endoskopiepumpe Master distributed by KARL STORZ UP033C, 115V, mit FussschalterArdo medical AGBTA2025-07-16
07640108055293Endoskopiepumpe Master distributed by KARL STORZ UP034C, 115VArdo medical AGBTA2025-07-16
00810149097997R&D Batteries, Inc.R & D Batteries, Inc.BTA2025-06-23
00810149097973R&D Batteries, Inc.R & D Batteries, Inc.BTA2025-06-18
00810149097980R&D Batteries, Inc.R & D Batteries, Inc.BTA2025-06-18
06975740361558MomcozyShenzhen Root Innovation Technology Co., Ltd.BTA2025-05-20
06978331170218BASENDongguan Yiyingmei Technology Co., Ltd.BTA2025-03-31
06978331170232BASENDongguan Yiyingmei Technology Co., Ltd.BTA2025-03-31