ALIMAXX-B®

Primary DI: 10884450031077
Brand: ALIMAXX-B®
Company: Merit Medical Systems, Inc.
Model: 00884450031070
Catalog number: 70129-206/C
Published: 2016-09-24
Public version status: Update
Distribution status: In Commercial Distribution
MRI safety: MR Conditional
Rx: false
OTC: false
Sterile: true
Single use: true

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
K093947	000

Premarket Details#

Submission, Supplement, Device table
Submission	Supplement	Device	Applicant	Decision date	Product code
K093947	000	ALIMAXX-B UNCOVERED BILIARY STENT SYSTEM ENDOSCOPIC	Merit Medical Systems, Inc.	2010-01-21	FGE

Identifiers And Packaging#

Identifier, Type, Agency table
Identifier	Type	Agency	Package quantity	Status
10884450031077	Package	GS1	1	In Commercial Distribution
00884450031070	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
10884450031077	10884450031077
00884450031070	00884450031070	884450031070	0884450031070

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
Device Size Text, specify	0
Device Size Text, specify	0

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number: 184763290
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DI	Brand	Model	Catalog	Published
00884450079973	Merit Medical®	Initial Release	K09-10089M	2026-06-09
00884450101537	Merit Medical®	Initial Release	K09-14320	2026-06-09
00884450101568	Merit Medical®	Initial Release	K09-14321	2026-06-09
00884450435748	SCOUT®	M	SG-01	2026-06-09
00884450486962	Merit Medical®	Initial Release	K09-14404	2026-06-09
00884450486993	Merit Medical®	Initial Release	K10-06203	2026-06-09
00884450767542	SCOUT MD™	B	SSCMD-01	2026-06-09
00884450826560	Fountain®	B	IS5-135-30	2026-06-09
10884450114008	Prelude IDeal™	H	PID4F11018SS	2026-06-09
10884450119799	Prelude EASE™	J	PHR6F11021PW	2026-06-09
00884450467572	DuraMax®	C	H787103028195	2026-06-08
00884450469033	BioFlo DuraMax®	B	H965103028161	2026-06-08
00884450469132	BioFlo DuraMax®	B	H965103028211	2026-06-08
00884450787663	Impress®	C	44038STS	2026-06-08
10884450114855	Prelude IDeal™	H	PID5F16021PW	2026-06-08
00884450030592	Merit Medical®	Initial Release	K08-02650A	2026-06-06
00884450107072	Merit Medical®	Initial Release	K09-13880A	2026-06-06
00884450110270	Merit Drainage Depot™	Initial Release	K10-03450A	2026-06-06
00884450161746	Merit Medical®	Initial Release	K09-10859C	2026-06-06
00884450376171	One-Tie®	A	LR-OTE-N	2026-06-06

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

ALIMAXX-B®

Related Records#

Product Codes#

Product Code Classifications#

Premarket Submissions#

Premarket Details#

Identifiers And Packaging#

Alternate GTIN / UPC / EAN Codes

GMDN Terms#

Device Sizes#

Sterilization Methods#

Regulatory Flags#

Other Devices From This Company#

Other Devices Sharing Product Codes#