FDA.reportPublic FDA data

Aligned Medical Solutions

Primary DI
B098AMS10930A0
Brand
Aligned Medical Solutions
Company
Aligned Medical Solutions
Model
AMS10930A
Catalog number
AMS10930A
Device description
Single Shot Epidural Tray
Published
2026-07-03
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
OGEEpidural Anesthesia Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OGEEpidural Anesthesia KitAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B098AMS10930A1PackageHIBCC30In Commercial Distribution
B098AMS10930A0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Epidural anaesthesia set, non-medicatedA collection of devices intended for the administration of an analgesic or anaesthetic agent (not included) to the epidural space for the management of pain. It includes a needle and/or a catheter with additional procedural devices (e.g., syringe, dressings, guidewire, introducer), and may be intended for single- or continuous-administration. It is not intended for intrathecal anaesthesia This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Contacts#

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

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850064198751Aligned Medical Solutions19254S19254S2026-09-23
B098AMS188430Aligned Medical SolutionsAMS18843AMS188432026-09-29
B098AMS194890Aligned Medical SolutionsAMS19489AMS194892026-09-29
B098AMS10256D0Aligned Medical SolutionsAMS10256DAMS10256D2026-09-28
B098AMS167320Aligned Medical SolutionsAMS16732AMS167322026-09-08
B098AMS178940Aligned Medical SolutionsAMS17894AMS178942026-09-28
B098AMS184330Aligned Medical SolutionsAMS18433AMS184332026-09-28
B098AMS192330Aligned Medical SolutionsAMS19233AMS192332026-09-28
B098AMS194460Aligned Medical SolutionsAMS19446AMS194462026-09-28
B098AMS197600Aligned Medical SolutionsAMS19760AMS197602026-09-28
B098AMS14766C0Aligned Medical SolutionsAMS14766CAMS14766C2026-09-26
B098AMS186920Aligned Medical SolutionsAMS18692AMS186922026-09-26
B098AMS195170Aligned Medical SolutionsAMS19517AMS195172026-09-26
B098AMS195240Aligned Medical SolutionsAMS19524AMS195242026-09-26
B098AMS196900Aligned Medical SolutionsAMS19690AMS196902026-09-25
B098AMS197760Aligned Medical SolutionsAMS19776AMS197762026-09-16
B098AMS197870Aligned Medical SolutionsAMS19787AMS197872026-09-02
B098AMS199160Aligned Medical SolutionsAMS19916AMS199162026-09-26
B098AMS199340Aligned Medical SolutionsAMS19934AMS199342026-09-26
B098AMS199930Aligned Medical SolutionsAMS19993AMS199932026-09-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10198956569386CARDINAL HEALTHCardinal Health 200, LLCOGE2026-09-29
10198956575615CARDINAL HEALTHCardinal Health 200, LLCOGE2026-09-29
B098AMS195170Aligned Medical SolutionsAligned Medical SolutionsOGE2026-09-26
10198956565982CARDINAL HEALTHCardinal Health 200, LLCOGE2026-09-25
10198956586543CARDINAL HEALTHCardinal Health 200, LLCOGE2026-09-25
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10198956564343CARDINAL HEALTHCardinal Health 200, LLCOGE2026-09-04
10198956564619CARDINAL HEALTHCardinal Health 200, LLCOGE2026-09-04
10198956565227CARDINAL HEALTHCardinal Health 200, LLCOGE2026-09-04
B098AMS198620Aligned Medical SolutionsAligned Medical SolutionsOGE2026-08-31
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04046955862658Design Options®B. BRAUN MEDICAL INC.OGE2026-08-17
B098AMS19234A0Aligned Medical SolutionsAligned Medical SolutionsOGE2026-08-16
00628725050218Clint Pharmaceuticals SINGLE SHOT EPIDURAL TRAYCHS USA Inc.OGE2026-08-07
00628725050225Clint Pharmaceuticals SINGLE SHOT EPIDURAL TRAYCHS USA Inc.OGE2026-08-07
00628725050317Clint Pharmaceuticals SINGLE SHOT EPIDURAL TRAYCHS USA Inc.OGE2026-08-07
00628725050348Clint Pharmaceuticals SINGLE SHOT EPIDURAL TRAYCHS USA Inc.OGE2026-08-07
00628725050386Clint Pharmaceuticals SINGLE SHOT EPIDURAL TRAYCHS USA Inc.OGE2026-08-07
10198956533097CARDINAL HEALTHCardinal Health 200, LLCOGE2026-07-31
10198956516847CARDINAL HEALTHCardinal Health 200, LLCOGE2026-07-27