FDA.reportPublic FDA data

Aligned Medical Solutions

Primary DI
B098R404ROJFB0
Brand
Aligned Medical Solutions
Company
Aligned Medical Solutions
Model
R404ROJFB
Catalog number
R404ROJFB
Device description
Amniocentesis Kit
Published
2025-03-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HIOSampler, Amniotic Fluid (Amniocentesis Tray)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HIOSampler, Amniotic Fluid (Amniocentesis Tray)Obstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B098R404ROJFB1PackageHIBCC20In Commercial Distribution
B098R404ROJFB0PrimaryHIBCC0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
1-800-637-7056customerservice@alignedmedical.com

Regulatory Flags#

DUNS number
106580145
Device count
1
Premarket exempt
true
Kit
true
Combination product
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B098AMS15842A0Aligned Medical SolutionsAMS15842AAMS15842A2026-11-05
B098AMS16505A0Aligned Medical SolutionsAMS16505AAMS16505A2026-11-05
B098AMS18938A0Aligned Medical SolutionsAMS18938AAMS18938A2026-11-05
B098AMS19018A0Aligned Medical SolutionsAMS19018AAMS19018A2026-11-05
B098AMS193710Aligned Medical SolutionsAMS19371AMS193712026-11-05
B098AMS195080Aligned Medical SolutionsAMS19508AMS195082026-11-04
B098AMS11396C0Aligned Medical SolutionsAMS11396CAMS11396C2026-11-03
B098AMS126380Aligned Medical SolutionsAMS12638AMS126382026-11-03
B098AMS194900Aligned Medical SolutionsAMS19490AMS194902026-10-02
B098AMS197430Aligned Medical SolutionsAMS19743AMS197432026-10-02
B098AMS202680Aligned Medical SolutionsAMS20268AMS202682026-11-03
B098AMS16175B0Aligned Medical SolutionsAMS16175BAMS16175B2026-10-26
B098AMS194890Aligned Medical SolutionsAMS19489AMS194892026-09-29
B098AMS14230A0Aligned Medical SolutionsAMS14230AAMS14230A2026-11-02
B098AMS15987A0Aligned Medical SolutionsAMS15987AAMS15987A2026-11-02
B098AMS18754A0Aligned Medical SolutionsAMS18754AAMS18754A2026-11-02
B098AMS18911A0Aligned Medical SolutionsAMS18911AAMS18911A2026-11-02
B098AMS19657A0Aligned Medical SolutionsAMS19657AAMS19657A2026-11-02
B098AMS198930Aligned Medical SolutionsAMS19893AMS198932026-11-02
B098AMS199380Aligned Medical SolutionsAMS19938AMS199382026-10-02

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Primary DI, Brand, Company table
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