FDA.reportPublic FDA data

RapidVac

Primary DI
20884524001071
Brand
RapidVac
Company
Covidien LP
Model
SEA3725
Catalog number
SEA3725
Device description
Smoke Wand
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FYDAPPARATUS, EXHAUST, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FYDApparatus, Exhaust, SurgicalGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K980915000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K980915000VALLEYLAB OPTIMUMM SMOKE EVACUATOR SYSTEMValleylab, Inc.1998-06-29FYD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884524001071PackageGS15In Commercial Distribution
10884524001074PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452400107120884524001071
1088452400107410884524001074

GMDN Terms#

Term, Definition table
TermDefinition
Suction/irrigation tubing, single-useA length of flexible noninvasive tube, typically made of synthetic polymer material(s), intended to interface between suction and/or irrigation devices (e.g., catheters, pumps, collection bottles) during a medical/surgical procedure. The tubing may be provided in rolls from which required lengths are cut, or may be provided in predetermined lengths with connectors; it does not include additional associated items such as a clamp, spike, or bag (i.e., not a tubing set). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length8Inch
Outer Diameter0.875Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity0 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature-29 Degrees Fahrenheit149 Degrees Fahrenheit
Special Storage Condition, Specify00;

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags#

DUNS number
058614483
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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
10884521102163Vascufil88864788-05V2015-08-31
10884522006545Shiley10DCFS2015-08-28
10884522030021Shiley5.0 PDL2015-09-15
10884522030083Shiley6.0 PDL2015-09-15
20884522029022Shiley8DCT2015-08-31
20884522029114Shiley4.5PDC2015-10-20
20884522031957Shiley10LPC-S2015-08-28
20884522031964Shiley4LPC-S2015-08-28
20884522031988Shiley8LPC-S2017-05-25
30884522026653Shiley3.0 NEO2015-09-15
30884522026684Shiley4.5 NEO2015-10-12
10884521833869EndoflipEF-301-RFB2024-04-12
10884521855359GI GeniusGGM300-US-RFB2026-07-26
10884521141742Endo GIAEGIARADXT2015-09-01
10884521703728Tri-Staple 2.0SIGCIR28MT2019-06-29
10884521703735Tri-Staple 2.0SIGCIR28XT2024-11-29
10884521703780Tri-Staple 2.0SIGCIR21MT2019-06-29
10884521703803Tri-Staple 2.0SIGCIR25MT2019-06-29
10884521758803Vascufil8886470311V-22020-07-19
10884521810365INVOSIS2021-08-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
30845854655492PlumeSafe® X5™Conmed CorporationFYD2026-07-23
10705036046523MegadyneETHICON ENDO-SURGERY, LLCFYD2026-05-27
10860012888808Flamingo Funnel (miniSQUAIR) - LargeNASCENT SURGICAL, LLCFYD2026-05-01
10860012888815Flamingo Funnel (microSQUAIR) - MediumNASCENT SURGICAL, LLCFYD2026-05-01
10860012888822Flamingo Funnel (nanoSQUAIR) - Small NASCENT SURGICAL, LLCFYD2026-05-01
20845854081751CONMED BUFFALO FILTERConmed CorporationFYD2024-03-25
10193489085341MedlineMEDLINE INDUSTRIES, INC.FYD2023-02-22
10193489085358MedlineMEDLINE INDUSTRIES, INC.FYD2023-02-22
10845854600085Smoke Shark IIIConmed CorporationFYD2021-02-12
10845854600092Smoke Shark IIIConmed CorporationFYD2021-02-12
20845854600105Smoke Shark IIIConmed CorporationFYD2021-01-20
40845854081830VIROSAFEConmed CorporationFYD2021-01-20
10845854082898BOVIE SharkSkinConmed CorporationFYD2021-01-07
40845854053127MEGADYNE MICROSAFEConmed CorporationFYD2020-12-08
10845854053096MINIVACConmed CorporationFYD2020-11-20
10845854053102MINIVACConmed CorporationFYD2020-11-20
20845854082802VIROSAFEConmed CorporationFYD2020-11-02
20845854081775OR-VACConmed CorporationFYD2020-10-23
20845854081058OR-VACConmed CorporationFYD2020-10-21
30845854081024OR-VACConmed CorporationFYD2020-10-21
30845854081031OR-VACConmed CorporationFYD2020-10-21
30845854081048OR-VACConmed CorporationFYD2020-10-21
30845854081680NAConmed CorporationFYD2020-10-14
20845854081706BOWAConmed CorporationFYD2020-09-30
20845854053192PENADAPTConmed CorporationFYD2020-09-17
20845854061814BOWAConmed CorporationFYD2020-09-15
20845854061821BOWAConmed CorporationFYD2020-09-15
20845854060015VIROSAFEConmed CorporationFYD2020-09-13
20845854081805HarmonyAIRConmed CorporationFYD2020-09-11
30845854053182BOWAConmed CorporationFYD2020-09-05