Morph Universal Deflectable Guide Catheter

Primary DI
00866749000202
Brand
Morph Universal Deflectable Guide Catheter
Company
BIOCARDIA, INC.
Model
00895
Catalog number
00895
Published
2016-10-10
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQOCatheter, Intravascular, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQOCatheter, Intravascular, DiagnosticCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K012749000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K012749000BIOCARDIA UNIVERSAL DEFLECTABLE GUIDE CATHETER, MODEL 000664Biocardia, Inc.2002-01-24DQO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00866749000202PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00866749000202008667490002028667490002020866749000202

GMDN Terms#

Term, Definition table
TermDefinition
Vascular guide-catheter, single-useA flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), needle or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section can have a variety of preformed shapes. It is not intended solely for infusion nor to access superselective small vessels, and does not include a transseptal needle. A percutaneous introduction set, shaft visualization electrodes, or haemostatic valve may be supplied with the guide-catheter. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
6502260120info@biocardia.com

Regulatory Flags#

DUNS number
122370146
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
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850007221003Avance Steerable IntroducerAVA85-115-20AVA85-115-202023-07-18
00850007221010Avance Steerable IntroducerAVA85-115-30AVA85-115-302023-07-18
00850007221027Avance Steerable CatheterAVA85-115-50AVA85-115-502023-07-18
00866749000295Morph DNADNA55-115-30DNA55-115-302023-07-17
00866749000240Morph AccessPro Steerable IntroducerMAP645MAP6452016-10-10
00866749000257Morph AccessPro Steerable IntroducerMAP690MAP6902016-10-10
00866749000271Helical Infusion Catheter00953L00953L2023-07-17

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