FDA.reportPublic FDA data

Twin Med LLC

Primary DI
00822383519024
Brand
Twin Med LLC
Company
Drive Devilbiss Healthcare
Model
18600-KIT2
Device description
800CCSuctionCanisterw/72"tubing, 48/BX
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does n
Rx
true
OTC
false
Sterile
false
Single use
false

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
K042349000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K042349000EMG MODEL SUA01 SUCTION UNITEmg Technology Co., Ltd.2004-12-16JCX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00822383519024PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00822383519024008223835190248223835190240822383519024

GMDN Terms#

Term, Definition table
TermDefinition
Nasal suction systemAn assembly of devices designed to evacuate obstructive secretions, gas, liquids (e.g., blood, vomitus), and/or foreign bodies from the upper respiratory tract (i.e., the nasal cavities and oropharynx). It generally consists of mains electricity (AC-powered) suction pump, a pressure regulator and gauge, one or more collection canisters, plastic tubes connecting the components to each other, and an overflow protection and/or bacteria filter. The typical vacuum level is low; free flow rates may be as high as 30 L/min. The system is used mainly in physician offices and for emergency procedures.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
867673159
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00023601061102Carex Health BrandsFGR11000 00002016-10-07
00092237614419Roscoe MedicalHUM-ROS62018-12-19
50050428250391DRIVEMEDICAL7417372019-06-21
00311917192352Walgreens9847282019-06-21
00822383989815DRIVEMEDICAL146-RTLPC23201-M2019-06-21
00822383989839DRIVEMEDICAL146-RTLPC23201-F2019-06-21
00822383246420DriveRTLPC23201-F2017-05-19
00822383037127Silver SportBIN-SSP316DDA-SF2026-06-22
00822383037134Silver SportBIN-SSP218DDA-SF2026-06-22
00822383037141Silver SportBIN-SSP220DDA-SF2026-06-22
00822383037158Cruiser 3 16"BIN-K316ADDA-SF2026-06-22
00822383037165Cruiser 3 18"BIN-K318ADDA-SF2026-06-22
00822383037172Cruiser 3 20"BIN-K320ADDA-SF2026-06-22
00194346283439EquateEQKW5002026-06-10
10092237600105Roscoe MedicalEP4070WCD2016-10-18
90002360125501AccuReliefACRL-55002016-10-12
00009223761699Reliable MedicalEF2020BC2-TU2018-06-13
00009223761941EswallowESW-90502016-12-31
00023601005144CAREX HEALTH BRANDSFGA51400 00002022-12-20
00023601005151CAREX HEALTH BRANDSFGA51500 BLUE2022-12-20

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Primary DI, Brand, Company table
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06978731720112Electric nasal aspiratorShenzhen Kingboom Technology Co., Ltd.BTA2026-10-12
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