FDA.report

ASAHI SASUKE

Primary DI
24547327120191
Brand
ASAHI SASUKE
Company
ASAHI INTECC CO., LTD.
Model
SA145-33N
Published
2019-08-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
DQYCatheter, percutaneous

Product Code Classifications

CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
24547327120191PackageGS11In Commercial Distribution
04547327120197PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
2454732712019124547327120191
04547327120197045473271201974547327120197

GMDN Terms

TermDefinition
Coronary artery infusion catheterA sterile flexible tube, typically with a double-lumen, designed to access the coronary artery vasculature for local infusion of diagnostic or therapeutic solutions (e.g., angiographic contrast medium, heparin solution, saline), and often to function as a passage for a guidewire to assist its placement in the coronary artery. This is a single-use device.

Device Sizes

TypeValueUnit
Length145Centimeter

Sterilization Methods

Method

Regulatory Flags

DUNS number
690711189
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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04547327165570ASAHI VelouteVEL125-16SNK2026-02-05
04547327165587ASAHI VelouteVEL150-16SNK2026-02-05
04547327165594ASAHI Veloute C3VEL105-16SNC3K2026-02-05
04547327165600ASAHI Veloute C3VEL125-16SNC3K2026-02-05
04547327165617ASAHI Veloute C3VEL150-16SNC3K2026-02-05
04547327165624ASAHI TellusTLS105-16SNK2026-02-05
04547327165631ASAHI TellusTLS125-16SNK2026-02-05
04547327165648ASAHI TellusTLS150-16SNK2026-02-05
04547327165655ASAHI Tellus C3TLS105-16SNC3K2026-02-05
04547327165662ASAHI Tellus C3TLS125-16SNC3K2026-02-05
04547327165679ASAHI Tellus C3TLS150-16SNC3K2026-02-05
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14547327163382CROSSLEAD Pro 018CPR01820S2025-12-15
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14547327163405CROSSLEAD Pro 018CPR01823S2025-12-15
14547327163412CROSSLEAD Pro 018CPR01823P2025-12-15
14547327163429CROSSLEAD Pro 018CPR01830S2025-12-15
14547327163436CROSSLEAD Pro 018CPR01830P2025-12-15

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