FDA.report

Aligned Medical Solutions

Primary DI
B098AMS2919B1
Brand
Aligned Medical Solutions
Company
Aligned Medical Solutions
Model
AMS2919B
Catalog number
AMS2919B
Device description
Left Heart Cath Pack
Published
2018-11-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
OEZCardiovascular procedure kit

Product Code Classifications

CodeDeviceSpecialtyClass
OEZCardiovascular Procedure KitCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B098AMS2919B1PackageHIBCC10In Commercial Distribution
B098AMS2919B0PrimaryHIBCC0

GMDN Terms

TermDefinition
Cardiothoracic surgical procedure kit, non-medicated, single-useA collection of various sterile cardiothoracic surgical instruments, dressings, and materials intended to be used to assist a range of cardiothoracic surgical procedures; it does not contain pharmaceuticals. The kit is intended only for use during cardiothoracic surgery but is not dedicated to a specific type of cardiothoracic surgical procedure. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1(888)637-7056customerservice@alignedmedical

Regulatory Flags

DUNS number
106580145
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
true
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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