FDA.reportPublic FDA data

Cook-Swartz

Primary DI
00827002213630
Brand
Cook-Swartz
Company
Cook Vandergrift Inc.
Model
G21363
Catalog number
DP-SDP001
Device description
Cook-Swartz Doppler Flow Probe Standard Cuff
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ITXTransducer, ultrasonic, diagnostic
JOPTRANSDUCER, ULTRASONIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITXTransducer, Ultrasonic, DiagnosticRadiology2
JOPTransducer, UltrasonicCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10827002213637PackageGS11In Commercial Distribution
00827002213630PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1082700221363710827002213637
00827002213630008270022136308270022136300827002213630

GMDN Terms#

Term, Definition table
TermDefinition
Blood flowmeter catheter, DopplerA device that is a flexible tube designed for insertion within the blood vessels for the purpose of determining blood-flow velocity by measuring the ultrasonic frequency shift between the transmitted and reflected signals (Doppler principle). It typically has a ceramic crystal attached at or near its distal tip that is capable of both transmitting and receiving ultrasound signals [20 megahertz (MHz) frequency is typical]. The proximal end is connected to a Doppler blood flowmeter unit where the measurements are displayed. It is typically used for measurement of the coronary haemodynamics (e.g., blood mean and peak velocity) during coronary procedures. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in dark, dry, cool place. Temperature limits to which the medical device can be safely exposed is -40 to +60 degrees Celsius. Humidity limitation - Non-condensing environment.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(812)330-5494sharedservices@cookmedical.com

Regulatory Flags#

DUNS number
056867526
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00827002260573Cook FlexipetG26057K-FPIP-1600-10BS-52016-09-24
00827002267114Cook FlexipetG26711K-FPIP-1130-10BS-52016-09-24
00827002267121Cook FlexipetG26712K-FPIP-1140-10BS-52016-09-24
00827002267138Cook FlexipetG26713K-FPIP-1170-10BS-52016-09-24
00827002327955CookG32795K-EBPH-30352016-09-24
00827002327993CookG32799K-EBPH-35352016-09-24
00827002460171Cook FlexipetG46017K-FPIP-1300-102016-09-24
00827002460188Cook FlexipetG46018K-FPIP-1170-102016-09-24
00827002460195Cook FlexipetG46019K-FPIP-1140-102016-09-24
00827002460201Cook FlexipetG46020K-FPIP-1300-10BS-52016-09-24
00827002460218Cook FlexipetG46021K-FPIP-1120-10BS-52016-09-24
10827002188782Cook FlexipetG18878K-FPIP-1300-10BS2016-09-24
10827002261812Cook FlexipetG26181K-FPIP-1080-10BS2016-09-24
10827002267180Cook FlexipetG26718K-FPIP-1100-10BS2016-09-24
00827002609891COOKG60989K-EBPH-20302025-07-24
00827002610132COOKG61013K-EBPH-20352025-07-24
00827002610149COOKG61014K-EBPH-25302025-07-24
00827002610156COOKG61015K-EBPH-25352025-07-24
10827002609898COOKG60989K-EBPH-20302025-07-24
10827002610139COOKG61013K-EBPH-20352025-07-24

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