FDA.reportPublic FDA data

Bovie

Primary DI
10607151011502
Brand
Bovie
Company
ASPEN SURGICAL PRODUCTS, INC.
Model
AD-330-A2W
Catalog number
AD-330-A2W
Device description
ACUDOP II 330, NON-DISPLAY UNIT WITH 2MHZ OB WATERPROOF PROBE
Published
2017-03-30
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
ITXTransducer, Ultrasonic, Diagnostic
LXEDoppler, Fetal, Ultrasound

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITXTransducer, Ultrasonic, DiagnosticRadiology2
LXEDoppler, Fetal, UltrasoundObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K090465000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090465000DIGDOP ULTRASOUND SYSTEMThe Newman Group, LLC2009-04-08ITX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10607151011502PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1060715101150210607151011502

GMDN Terms#

Term, Definition table
TermDefinition
Foetal Doppler systemA portable, hand-held, battery-powered device assembly consisting of a measuring and display unit and an attached probe or interchangeable probes designed to noninvasively detect foetal heart beats using ultrasound/Doppler technology. The heart beats are typically conveyed audibly via the measuring/display unit and attached probe which is applied to the surface of the pregnant woman's abdomen. The device aids in determining foetal viability.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity00
Storage Environment Temperature00

Regulatory Flags#

DUNS number
027680821
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
10840113232908BovieAA002026-09-21
10840113232922BovieAA00X2026-09-21
10840113232946BovieAA012026-09-21
10840113232960BovieAA01X2026-09-21
10840113232984BovieAA022026-09-21
10840113233004BovieAA032026-09-21
10840113233028BovieAA03X2026-09-21
10840113233042BovieAA042026-09-21
10840113233066BovieAA04X2026-09-21
10840113233080BovieAA052026-09-21
10840113233165BovieAA212026-09-21
10840113233189BovieAA21X2026-09-21
10840113233264BovieAA902026-09-21
10840113233547BovieAA05X2026-09-21
10840113234407BovieES232026-09-21
10840113234414BovieES22-82026-09-21
10840113236838BovieES032026-09-21
10840113236845BovieES022026-09-21
10840113236852BovieES02T2026-09-21
10840113236876BovieES012026-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00195278985613NAGE Medical Systems (China) Co.,Ltd.ITX2026-09-24
00198953126073VividGE Vingmed Ultrasound A/SITX2026-09-21
00198953172384VividGE Vingmed Ultrasound A/SITX2026-09-21
00198953172551VividGE Vingmed Ultrasound A/SITX2026-09-21
00884838128095Affiniti 50 Diagnostic Ultrasound SystemPhilips Ultrasound LLCITX2026-09-18
00884838128101Affiniti 70 Diagnostic Ultrasound SystemPhilips Ultrasound LLCITX2026-09-18
00884838128118Affiniti 30 Diagnostic Ultrasound SystemPhilips Ultrasound LLCITX2026-09-18
00884838128125EPIQ Elite Diagnostic Ultrasound SystemPhilips Ultrasound LLCITX2026-09-18
03701104600420T-LiteSONOSCANNERITX2026-08-25
04580826920721PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826920769PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826920806PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826926365PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826926396PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826926501PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826926518PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826926532PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826926556PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826927881PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826928291PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826928468PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826928628PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826928703PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826928956PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
08800290029376CA2-13MSAMSUNG MEDISON CO., LTD.ITX2026-08-18
08800290036169PA2-9SSAMSUNG MEDISON CO., LTD.ITX2026-08-18
08800290036237BCC2-13SAMSUNG MEDISON CO., LTD.ITX2026-08-18
08800357291937V6 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.ITX2026-08-18
08800357300165V7 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.ITX2026-08-18
08800357308208V8 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.ITX2026-08-18