FDA.reportPublic FDA data

Sun Medical Inc

Primary DI
B226842142
Brand
Sun Medical Inc
Company
SUN MEDICAL INC
Model
84214
Catalog number
84214
Device description
14mm Curved Cannula
Published
2017-01-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HDBExtractor, Vacuum, Fetal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HDBExtractor, Vacuum, FetalObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B226842142PrimaryHIBCC0
B842142Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Suction cannula, single-useA sterile, rigid or semi-rigid, hand-held plastic tube designed as a conduit for the evacuation (suctioning) of blood, fluids, and other tissue debris directly from the surgical site during a surgical procedure (e.g., open- or plastic surgery). Also known as a suction tube, it is typically a general-purpose device to which the suction system tubing is connected proximally; some types may be attached to a dedicated handpiece that typically have a valve. Dedicated cannula specifically intended for a particular procedure (e.g., bronchial, dental, eye, uterine, oral, and liposuction) are also available. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter14Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
9033569000Spolk@sunmedicalinc.com

Regulatory Flags#

DUNS number
095223103
Device count
25
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B22687300000Sun Medical Inc873000087300002017-01-23
B22687300001Sun Medical Inc873000087300002017-01-23
B22691200000Sun Medical IncSFE20091200002017-01-23
B226841080Sun Medical Inc84108841082016-08-02
B226841082Sun Medical Inc84108841082017-01-23
B226841100Sun Medical Inc84110841102017-01-23
B226841102Sun Medical Inc84110841102017-01-23
B226841120Sun Medical Inc84112841122017-01-23
B226841122Sun Medical Inc841128411222017-01-23
B226841140Sun Medical Inc84114841142017-01-23
B226841142Sun Medical Inc84114841142017-01-23
B226842080Sun Medical Inc84208842082017-01-23
B226842082Sun Medical Inc84208842082017-01-23
B226842100Sun Medical Inc84210842102017-01-23
B226842102Sun Medical Inc84210842102017-01-23
B226842120Sun Medical Inc84212842122017-01-23
B226842122Sun Medical Inc84212842122017-01-23
B226842140Sun Medical Inc84214842142017-01-23
B226843000Sun Medical INc84300843002017-01-23
B226843002Sun Medical Inc84300843002017-01-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00814247021243Kiwi® OmniCup®CLINICAL INNOVATIONS, LLCHDB2025-12-16
07612367000109Silicone tubing ID 6.5mm, 180cm, 1 coupling pieceMedela AGHDB2024-05-31
07612367003551Quiver 280mmMedela AGHDB2024-05-31
07612367003568Quiver 480mmMedela AGHDB2024-05-31
07612367003575Change over valveMedela AGHDB2024-05-31
07612367003698Overflow protection deviceMedela AGHDB2024-05-31
07612367003735Reusable serial connectorMedela AGHDB2024-05-31
07612367003742Safety Set for railholderMedela AGHDB2024-05-31
07612367003896Tubing holder left sideMedela AGHDB2024-05-31
07612367003902Tubing holder right sideMedela AGHDB2024-05-31
07612367004275Silicone tube, ID 7mm, 100cmMedela AGHDB2024-05-31
07612367004688Holder for 1L/1.5L jar, leftMedela AGHDB2024-05-31
07612367004695Holder for 1L/1.5L jar, rightMedela AGHDB2024-05-31
07612367004701Holder for 2L/2.5L jar, leftMedela AGHDB2024-05-31
07612367004718Holder for 2L/2.5L jar, rightMedela AGHDB2024-05-31
07612367008242Double conical coupling pieceMedela AGHDB2024-05-31
07612367008655Silicone tube, ID 7mm, 33cmMedela AGHDB2024-05-31
07612367009928Y-pieceMedela AGHDB2024-05-31
07612367011204Vario Filter set, bacteria & overflowMedela AGHDB2024-05-31
07612367011372Single set 1lMedela AGHDB2024-05-31
07612367011389Single set 2lMedela AGHDB2024-05-31
07612367011600Single set 2l, clampholderMedela AGHDB2024-05-31
07612367017329Single set 1l, clampholderMedela AGHDB2024-05-31
07612367017336Single set 3l, clampholderMedela AGHDB2024-05-31
07612367017343Single set 5l, clampholderMedela AGHDB2024-05-31
07612367017350Double set 3lMedela AGHDB2024-05-31
07612367017367Double set 5lMedela AGHDB2024-05-31
07612367038225Double set 2lMedela AGHDB2024-05-31
07612367047692Trolley A for DCSMedela AGHDB2024-05-31
07612367051033Trolley B for DCSMedela AGHDB2024-05-31