FDA.reportPublic FDA data

Bovie

Primary DI
10607151001664
Brand
Bovie
Company
BOVIE MEDICAL CORPORATION
Model
SERF
Catalog number
SERF
Device description
REDUCER FITTING 7/8" (2.22cm) TO ¼" (.63cm) X WITH ¼" (.63cm) X 24” (60.96CM) MEDICAL (PVC) TUBING (10 PER POUCH)
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
GAZTubing, Noninvasive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAZTubing, NoninvasiveGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10607151001664PackageGS110In Commercial Distribution
00607151001667PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1060715100166410607151001664
00607151001667006071510016676071510016670607151001667

GMDN Terms#

Term, Definition table
TermDefinition
Surgical plume evacuation system tubeA sterile, long, hollow cylinder which, as part of a surgical smoke evacuation system, is used to capture and conduct to exhaust the plume generated during open surgical procedures in which there is tissue ablation (e.g., laser surgery, electrocautery, electrosurgical diathermy device). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079940465
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
00607151009854BovieE15646E156462020-11-16
00607151009861BovieE15644E156442020-11-16
00607151009878BovieE15596E155962020-11-16
00607151009885BovieE15606E156062020-11-16
00607151009892BovieE15616E156162020-11-16
00607151009908BovieE15626E156262020-11-16
00607151009915BovieE15594E155942020-11-16
00607151009922BovieE15604E156042020-11-16
00607151009939BovieE15614E156142020-11-16
00607151009946BovieE15624E156242020-11-16
00607151009953BovieE16512E165122020-11-16
00607151009960BovieE16514E165142020-11-16
10607151010796BOVIEBA3350ABA3350A2016-10-07
10607151010819BOVIEBA3390ABA3390A2016-10-07
10607151010826BOVIEBA3390NABA3390NA2016-10-07
10607151010833BOVIEBA3350NABA3350NA2016-10-07
10607151010840BOVIEBA2455NABA2455NA2016-10-07
10607151010857BOVIEBA1860NABA1860NA2016-10-07
10607151007604J-PLASMA® GS-270CGS-270C2016-09-21
10607151007819J-PLASMA® GS-018CGS-018C2016-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10080196144310MEDLINEMEDLINE INDUSTRIES, INC.GAZ2026-06-08
10884389123997MEDLINEMEDLINE INDUSTRIES, INC.GAZ2026-06-08
14026704937360PLEUR-EVACTELEFLEX INCORPORATEDGAZ2026-05-08
16931918141206AllesetGRI Medical & Electronic Technology Co., Ltd.GAZ2025-06-20
10080196035106MEDLINEMEDLINE INDUSTRIES, INC.GAZ2025-04-25
10080196035120MEDLINEMEDLINE INDUSTRIES, INC.GAZ2025-04-25
10080196035151MEDLINEMEDLINE INDUSTRIES, INC.GAZ2025-04-25
10080196035168MEDLINEMEDLINE INDUSTRIES, INC.GAZ2025-04-25
10080196035229MEDLINEMEDLINE INDUSTRIES, INC.GAZ2025-04-25
10080196035243MEDLINEMEDLINE INDUSTRIES, INC.GAZ2025-04-25
10080196035250MEDLINEMEDLINE INDUSTRIES, INC.GAZ2025-04-25
10080196996063MEDLINEMEDLINE INDUSTRIES, INC.GAZ2025-04-25
10192253042917ArgyleCardinal Health 200, LLCGAZ2025-02-27
10192253043051ArgyleCardinal Health 200, LLCGAZ2025-02-27
14026704933119PLEUR-EVACTELEFLEX INCORPORATEDGAZ2024-11-18
08809083944803EvaQMax LaparoBIOPROTECH INC.GAZ2024-08-28
08809083944810EvaQMax LaparoBIOPROTECH INC.GAZ2024-08-28
08809083944827EvaQMax LaparoBIOPROTECH INC.GAZ2024-08-28
08809083944834EvaQMax LaparoBIOPROTECH INC.GAZ2024-08-28
08809083944841EvaQMax LaparoBIOPROTECH INC.GAZ2024-08-28
08809083944858EvaQMax LaparoBIOPROTECH INC.GAZ2024-08-28
08809083944865EvaQMax LaparoBIOPROTECH INC.GAZ2024-08-28
08809083944872EvaQMax LaparoBIOPROTECH INC.GAZ2024-08-28
08809083944889EvaQMax LaparoBIOPROTECH INC.GAZ2024-08-28
08809083944896EvaQMax LaparoBIOPROTECH INC.GAZ2024-08-28
08809083944902EvaQMax LaparoBIOPROTECH INC.GAZ2024-08-28
08809083944919EvaQMax LaparoBIOPROTECH INC.GAZ2024-08-28
08809083944926EvaQMax LaparoBIOPROTECH INC.GAZ2024-08-28
20192253051909ArgyleCardinal Health 200, LLCGAZ2024-08-20
20192253051893ArgyleCardinal Health 200, LLCGAZ2024-08-19