Paramount Mini GPS

Primary DI: 00821684006405
Brand: Paramount Mini GPS
Company: Covidien LP
Model: PMB4-7-14-80
Device description: Balloon-Expandable Biliary Stent System
Published: 2015-10-16
Public version status: Update
Distribution status: In Commercial Distribution
MRI safety: Labeling does not contain MRI Safety Information
Rx: true
Sterile: true
Single use: true

Contact Domains#

covidien.com

Product Codes#

Code, Name table
Code	Name
FGE	CATHETER, BILIARY, DIAGNOSTIC

Product Code Classifications#

Code, Device, Specialty table
Code	Device	Specialty	Class
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	2

Premarket Submissions#

Submission, Supplement table
Submission	Supplement
K040653	000

Premarket Details#

Submission, Supplement, Device table
Submission	Supplement	Device	Applicant	Decision date	Product code
K040653	000	PARAMOUNT MINI GPS BILIARY STENT SYSTEM	Ev3, Inc.	2004-04-28	FGE

Identifiers And Packaging#

Identifier, Type, Agency table
Identifier	Type	Agency	Package quantity	Status
00821684006405	Primary	GS1	0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifier	GTIN-14 normalized	UPC-A	EAN-13
00821684006405	00821684006405	821684006405	0821684006405

GMDN Terms#

Term, Definition table
Term	Definition
Bare-metal biliary stent	A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. It may be a mesh structure or a continuous tube and is made entirely of metal [e.g., high-grade stainless steel, cobalt-chrome (Co-Cr), nickel-titanium alloy (Nitinol)]. It may be expandable in situ (e.g., with a balloon catheter or self-expands) and disposable devices intended to assist implantation may be included.

Device Sizes#

Type, Value, Unit table
Type	Value	Unit
Catheter Gauge	6	French
Device Size Text, specify	0
Length	14	Millimeter
Outer Diameter	7	Millimeter

Storage And Handling#

Type, Low, High table
Type	Low	High	Condition
Special Storage Condition, Specify	0	0	Keep Dry
Special Storage Condition, Specify	0	0	Keep Dry;AVOID DIRECT SUNLIGHT

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
Phone	Email
+1(508)261-8000	covidien.udi@covidien.com

Regulatory Flags#

DUNS number: 968903703
Device count: 1
Lot or batch: true
Expiration date on label: true

Other Devices From This Company#

Primary DI, Brand, Model table
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10884521091986	Nellcor	SC-A-I	2026-05-25
10884521758803	Vascufil	8886470311V-2	2020-07-19
10884521816312	McGRATH MAC	350-005-000	2021-10-21
10884521816329	McGRATH MAC	350-013-000	2021-08-30
10884521816336	McGRATH MAC	350-017-000	2021-10-18
10884521816343	McGRATH MAC	350-072-000	2022-06-13
10884521824317	McGRATH MAC	350-005-000	2022-09-25
10884521824324	McGRATH MAC	350-013-000	2021-10-30
10884521824331	McGRATH MAC	350-017-000	2021-08-26
10884521824348	McGRATH MAC	350-072-000	2023-06-19
10884521850118	McGRATH MAC	350-005-000	2025-04-27
10884521850125	McGRATH MAC	350-013-000	2025-04-27
10884521850132	McGRATH MAC	350-017-000	2025-04-27
10884521850149	McGRATH MAC	350-072-000	2025-04-27
15060272980310	McGRATH MAC	350-005-000	2021-08-02
15060272980327	McGRATH MAC	350-013-000	2022-01-17
15060272980334	McGRATH MAC	350-072-000	2021-04-18
15060272980341	McGRATH MAC	350-017-000	2021-03-27

Primary DI, Brand, Company table
Primary DI	Brand	Company	Product code	Published
15711055100400	M-Drain	Mermaid Medical A/S	FGE	2024-10-01
15711055110041	M-Drain	Mermaid Medical A/S	FGE	2024-07-20
15711055110409	M-Drain	Mermaid Medical A/S	FGE	2024-07-20
15711055120040	M-Drain	Mermaid Medical A/S	FGE	2024-01-31
15711055120453	M-Drain	Mermaid Medical A/S	FGE	2024-01-31
15711055000311	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000328	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000359	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000373	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000410	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000434	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000458	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000472	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000496	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000519	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000533	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000557	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000588	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000595	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000625	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000632	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000663	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000670	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000700	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000724	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000748	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000762	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000779	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000809	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000816	M-Drain	Mermaid Medical A/S	FGE	2016-09-24

Paramount Mini GPS

Related Records#

Contact Domains#

Product Codes#

Product Code Classifications#

Premarket Submissions#

Premarket Details#

Identifiers And Packaging#

Alternate GTIN / UPC / EAN Codes

GMDN Terms#

Device Sizes#

Storage And Handling#

Sterilization Methods#

Contacts#

Regulatory Flags#

Other Devices From This Company#

Other Devices Sharing Product Codes#