BEUDAMED

FDA UDI In Commercial Distribution 🇺🇸 United States

Aligned Medical Solutions

DI: B098AMS166010 · Model: AMS16601 · Aligned Medical Solutions

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Product Codes

1

GMDN Terms

1

Identifiers

2

Pkg Device Count

1

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Basic Information

Brand Name: Aligned Medical Solutions
Primary DI: B098AMS166010
Version / Model: AMS16601
Catalog Number: AMS16601
Company Name: Aligned Medical Solutions
Labeler DUNS: 106580145
Distribution Status: In Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2024-12-10
Public Version: 1
Public Version Date: 2024-12-18
Public Version Status: New
Public Device Record Key: a6646dc6-83da-4359-bfe6-aad9f69cb3db

Device Description

Loop Pack

Device Characteristics

Single Use: Yes
Prescription Use (Rx): Yes
Over the Counter (OTC): No
Kit: Yes
Combination Product: No
HCT/P: No
Contains NRL: Yes
Not Made with NRL: No
MRI Safety: Labeling does not contain MRI Safety Information
Direct Marking Exempt: No
PM Exempt: Yes
Has Serial Number: No
Has Lot/Batch Number: Yes
Has Manufacturing Date: Yes
Has Expiration Date: Yes
Has Donation ID: No

Sterilization

Is Sterile: Yes
Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OEQ	Angiography/Angioplasty Kit	Cardiovascular	870.1650	2

GMDN Terms

Code	Name	Definition	Implantable	Status
16545	Angiography kit	A collection of sterile devices and equipment used to prepare a patient for the radiographic visualization of the arteries of a particular organ system or body part through the vascular injection of contrast media. It typically includes a combination of fluid/contrast media administration devices (e.g., tubing, manifold, stopcocks, and syringes) and/or dedicated angiography supportive devices (e.g., angiography drapes, covers, dressings); the angiography catheter is not included. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	B098AMS166011	HIBCC	Case	6	In Commercial Distribution
Primary	B098AMS166010	HIBCC

Customer Contacts

Phone: 1-800-637-7056
Email: [email protected]

Storage Conditions

Type: Storage Environment Temperature
Temperature Range: 15 – 30 Degrees Celsius