FDA.reportPublic FDA data

Instavac I

Primary DI
08688250002580
Brand
Instavac I
Company
OHIO MEDICAL, LLC
Model
Instavac I
Device description
Portable Suction Pump
Published
2017-01-05
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
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
K933902000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K933902000MOBLVAC IIIAeros Instruments, Inc.1994-05-20BTA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08688250002580PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08688250002580086882500025808688250002580

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose surgical suction system, electricA portable assembly of devices, which includes a surgically invasive component, intended to aspirate body cavities/wounds during a surgical procedure (e.g., general surgery, laparoscopy, urological surgical procedure); it may in addition have non-surgical applications. It is typically intended to remove debris, tissues and fluids, to clear a site and facilitate observation. It includes an electrically-powered suction pump, collection containers, tubing, and patient contact devices (e.g., handpiece/tip, catheter); it is not designed for irrigation.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18478550500customer.service@ohiomedical.com

Regulatory Flags#

DUNS number
005192885
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00628101624248OhioFM-LT-1515NOFM-LT-1515NO2026-10-22
00628101624385OhioFM-LT-0303NOFM-LT-0303NO2026-10-22
00628101624392OhioFM-T-0101NOFM-T-0101NO2026-10-22
00628101624408OhioFM-T-0303NOFM-T-0303NO2026-10-22
00628101624415OhioFM-T-1515NOFM-T-1515NO2026-10-22
00628101629236OhioFM-LT-1515UOFM-LT-1515UO2026-10-22
00628101629243OhioFM-OT-1515UOFM-OT-1515UO2026-10-22
00628101629250OhioFM-T-1515UOFM-T-1515UO2026-10-22
00628101629922OhioFM-T-1515NAFM-T-1515NA2026-10-22
00628101629939OhioFM-OT-1515NOFM-OT-1515NO2026-10-22
00628101630379OhioFM-OT-1515NAFM-OT-1515NA2026-10-22
00628101630386OhioFM-T-1515IOFM-T-1515IO2026-10-22
00628101630454OhioFM-T-1515UAFM-T-1515UA2026-10-22
00628101630461OhioFM-OT-0315UOFM-OT-0315UO2026-10-22
00628101630683OhioFM-LT-1515SOFM-LT-1515SO2026-10-22
00628101631093OhioFM-T-0101IOFM-T-0101IO2026-10-22
00628101631109OhioFM-T-0101UOFM-T-0101UO2026-10-22
00628101631116OhioFM-T-0303IOFM-T-0303IO2026-10-22
00628101631123OhioFM-T-0303UOFM-T-0303UO2026-10-22
00628101631130OhioFM-T-0808IOFM-T-0808IO2026-10-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06978731720013Electric nasal aspiratorShenzhen Kingboom Technology Co., Ltd.BTA2026-10-12
06978731720020Electric nasal aspiratorShenzhen Kingboom Technology Co., Ltd.BTA2026-10-12
06978731720037Electric nasal aspiratorShenzhen Kingboom Technology Co., Ltd.BTA2026-10-12
06978731720044Electric nasal aspiratorShenzhen Kingboom Technology Co., Ltd.BTA2026-10-12
06978731720051Electric nasal aspiratorShenzhen Kingboom Technology Co., Ltd.BTA2026-10-12
06978731720068Electric nasal aspiratorShenzhen Kingboom Technology Co., Ltd.BTA2026-10-12
06978731720075Electric nasal aspiratorShenzhen Kingboom Technology Co., Ltd.BTA2026-10-12
06978731720082Electric nasal aspiratorShenzhen Kingboom Technology Co., Ltd.BTA2026-10-12
06978731720099Electric nasal aspiratorShenzhen Kingboom Technology Co., Ltd.BTA2026-10-12
06978731720105Electric nasal aspiratorShenzhen Kingboom Technology Co., Ltd.BTA2026-10-12
06978731720112Electric nasal aspiratorShenzhen Kingboom Technology Co., Ltd.BTA2026-10-12
06970289030866foreverlittleHetaida Technology Co., LtdBTA2026-07-28
00842429118689MV Flow Aspiration PumpMicrovention, Inc.BTA2026-07-15
06970462546832Suction PumpShenzhen HugeMed Medical Technical Development Co., Ltd.BTA2026-06-04
00860014862731HEYVALUEOak Tech LLCBTA2026-03-27
00860014862748GROWNSYOak Tech LLCBTA2026-03-27
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