FDA.reportPublic FDA data

SiteSeer™

Primary DI
20613994894148
Brand
SiteSeer™
Company
MEDTRONIC, INC.
Model
4A0068
Device description
CATHETER 4A0068 SS 5PK 4F JL 4.5I 100CM
Published
2016-06-12
Public version status
Update
Distribution status
Not 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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20613994894148PackageGS15Not in Commercial Distribution
00613994894144PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2061399489414820613994894148
00613994894144006139948941446139948941440613994894144

GMDN Terms#

Term, Definition table
TermDefinition
Angiographic catheter, single-useA thin, flexible tube designed to inject a contrast medium into select blood vessels of the cerebral, visceral, or peripheral vasculature during an angiographic procedure in order to facilitate the clear visualization of the vascular system of a targeted organ or area of the body. It is introduced percutaneously, has a radiopaque marker(s) for positioning, and may include disposable devices dedicated to catheter introduction/function [e.g., sheath(s)]. It may also be used for simultaneous pressure measurements to determine the transvalvular, intravascular, and intraventricular pressure gradients. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Lumen/Inner Diameter1.07Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store catheters in a cool, dry area.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
006261481
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
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
00613994963826NIH™0087612016-07-24
00613994964274NIH™ Cardio-Marker0100112016-06-10
00613994964540Lehman™0012592016-06-05
00613994964564Lehman™0012632016-06-05
00613994964120Sones™ Brachial9907072016-06-05
00613994964748Goodale-Lubin™0074602016-06-05
00681490860659DLPCB140172016-05-22
00199150006038N/ATM91D02026-05-23
00199150080649NABB12S94R52026-05-23
00199150080694NABB12V43R12026-05-23
00199150080700NABB11E27R32026-05-23
00199150081004NABB11J58R82026-05-23
00199150081011NABB12T50R32026-05-23
00199150081035NABB7E31R342026-05-22
00199150081042NA12D63R22026-05-22
00199150081066NA4J31R12026-05-23
00199150081707NABB11J59R92026-05-22
00199150081714NABB11U73R22026-05-23
00199150081738NABB11J16R32026-05-22
00199150081745NA9M68R12026-05-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10884450788407Impress®Merit Medical Systems, Inc.DQO2026-03-21
10884450787080Impress®Merit Medical Systems, Inc.DQO2026-03-19
50690103218607SWAN-GANZ TRUE SIZEEdwards Lifesciences LLCDQO2026-03-16
10884450710729Impress®Merit Medical Systems, Inc.DQO2026-03-11
20841156111486LANGSTONTELEFLEX INCORPORATEDDQO2026-03-11
10884450787103Impress®Merit Medical Systems, Inc.DQO2026-03-03
10884450787455Impress®Merit Medical Systems, Inc.DQO2026-03-03
10884450788070Impress®Merit Medical Systems, Inc.DQO2026-02-19
10884450787653Impress®Merit Medical Systems, Inc.DQO2026-02-14
10884450852849Impress®Merit Medical Systems, Inc.DQO2026-02-14
50690103000417SWAN-GANZEdwards Lifesciences LLCDQO2026-01-30
00884450722329Impress®Merit Medical Systems, Inc.DQO2026-01-28
10884450787516Impress®Merit Medical Systems, Inc.DQO2026-01-23
10884450788124Impress®Merit Medical Systems, Inc.DQO2026-01-23
10884450787059Impress®Merit Medical Systems, Inc.DQO2026-01-22
10884450787837Impress®Merit Medical Systems, Inc.DQO2026-01-22
04987350744487DUALVIEWTERUMO CORPORATIONDQO2026-01-21
10884450787271Impress®Merit Medical Systems, Inc.DQO2026-01-16
10884450787530Impress®Merit Medical Systems, Inc.DQO2026-01-16
10884450788797Impress®Merit Medical Systems, Inc.DQO2026-01-16
10884450787721Impress®Merit Medical Systems, Inc.DQO2026-01-13
10884450787745Impress®Merit Medical Systems, Inc.DQO2026-01-13
10884450787707Impress®Merit Medical Systems, Inc.DQO2026-01-03
10884450787752Impress®Merit Medical Systems, Inc.DQO2026-01-03
10884450835934Performa®Merit Medical Systems, Inc.DQO2026-01-03
10884450787813Impress®Merit Medical Systems, Inc.DQO2025-12-24
10884450787820Impress®Merit Medical Systems, Inc.DQO2025-12-24
10884450787547Impress®Merit Medical Systems, Inc.DQO2025-12-23
10884450788650Impress®Merit Medical Systems, Inc.DQO2025-12-23
10884450787387Impress®Merit Medical Systems, Inc.DQO2025-12-20