FDA.reportPublic FDA data

Cook

Primary DI
00827002554580
Brand
Cook
Company
Cook Vandergrift Inc.
Model
G55458
Catalog number
DP-M350-CHG1
Device description
Charger For Blood Flow Monitor - DP-M350 - Non-Sterile
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JOPTRANSDUCER, ULTRASONIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOPTransducer, UltrasonicCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00827002554580PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002554580008270025545808270025545800827002554580

GMDN Terms#

Term, Definition table
TermDefinition
Noninvasive device battery chargerAn electrically-powered device designed to supply an electrical charge, via a direct/wired or wireless connection, to the battery of a noninvasive device to recharge it for operation; it is not intended to receive data from and transmit data to other devices (i.e., not a transceiver). It is typically in the form of an electronic circuitry housing with a cable.

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

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
00888937029536CooperSurgical® Coopersurgical, Inc.JOP2026-04-10
G677H1V06VasoGuardCorVascularJOP2026-04-08
G677H1V08VasoGuardCorVascularJOP2026-04-08
G677H1V10VasoGuardCorVascularJOP2026-04-08
G677H2V02VasoGuardCorVascularJOP2026-04-08
G677H2V04VasoGuardCorVascularJOP2026-04-08
G677VG0201VasoGuardCorVascularJOP2026-04-08
G677VG0401VasoGuardCorVascularJOP2026-04-08
G677VG0601VasoGuardCorVascularJOP2026-04-08
G677VG0801VasoGuardCorVascularJOP2026-04-08
G677VG1001VasoGuardCorVascularJOP2026-04-08
00888937027815CooperSurgical® Coopersurgical, Inc.JOP2026-04-01
00888937027839CooperSurgical® Coopersurgical, Inc.JOP2026-04-01
00888937027808CooperSurgical® Coopersurgical, Inc.JOP2026-01-23
00888937027822CooperSurgical® Coopersurgical, Inc.JOP2025-09-25
07290016880441Detachable PPG Clip sensorVIASONIX LTDJOP2024-12-27
07290016880533Falcon/XpressVIASONIX LTDJOP2024-12-27
07290016880489Pressure Cuff Size 12LVIASONIX LTDJOP2023-06-29
07290016880496Pressure Cuff Size 2.5VIASONIX LTDJOP2023-06-29
07290016880502Pressure Cuff Size 1.9VIASONIX LTDJOP2023-06-29
07290016880519Pressure Cuff Size 1.6VIASONIX LTDJOP2023-06-29
07290016880526Pressure Cuff Size 7VIASONIX LTDJOP2023-06-29
07290016880472Pressure Cuff Size 12VIASONIX LTDJOP2023-06-25
07290016880465Pressure Cuff Size 10VIASONIX LTDJOP2023-06-23
072900168803974 MHz probe VIASONIX LTDJOP2022-08-08
072900168804038 MHz probe VIASONIX LTDJOP2022-08-08
0729001688041010 MHz probe VIASONIX LTDJOP2022-08-08
008167870243193.9MHz Pencil Probe 7 Foot ODU connectorPARKS MEDICAL ELECTRONICS, INC.JOP2022-05-15
008167870243268.1MHz Pencil Probe 7 Foot ODU connectorPARKS MEDICAL ELECTRONICS, INC.JOP2022-05-15
008167870243338.3MHz Pencil Probe 7 Foot ODU connectorPARKS MEDICAL ELECTRONICS, INC.JOP2022-05-15