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
B098AMS131940Aligned Medical SolutionsAMS13194AMS131942026-07-26
B098AMS131950Aligned Medical SolutionsAMS13195AMS131952026-07-26
B098AMS131960Aligned Medical SolutionsAMS13196AMS131962026-07-25
B098AMS13932C0Aligned Medical SolutionsAMS13932CAMS13932C2026-07-25
B098AMS14766B0Aligned Medical SolutionsAMS14766BAMS14766B2026-07-26
B098AMS16019B0Aligned Medical SolutionsAMS16019BAMS16019B2026-07-25
B098AMS17798A0Aligned Medical SolutionsAMS17798AAMS17798A2026-07-26
B098AMS17843A0Aligned Medical SolutionsAMS17843AAMS17843A2026-07-25
B098AMS179150Aligned Medical SolutionsAMS17915AMS179152026-07-26
B098AMS18256A0Aligned Medical SolutionsAMS18256AAMS18256A2026-07-25
B098AMS187260Aligned Medical SolutionsAMS18726AMS187262026-07-25
B098AMS188360Aligned Medical SolutionsAMS18836AMS188362026-07-26
B098AMS189110Aligned Medical SolutionsAMS18911AMS189112026-07-26
B098AMS190180Aligned Medical SolutionsAMS19018AMS190182026-07-26
B098AMS190570Aligned Medical SolutionsAMS19057AMS190572026-07-25
B098AMS190730Aligned Medical SolutionsAMS19073AMS190732026-07-26
B098AMS190920Aligned Medical SolutionsAMS19092AMS190922026-07-26
B098AMS190930Aligned Medical SolutionsAMS19093AMS190932026-07-26
B098AMS193930Aligned Medical SolutionsAMS19393AMS193932026-07-26
B098AMS194550Aligned Medical SolutionsAMS19455AMS194552026-07-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04046955966288Design Options®B. BRAUN MEDICAL INC.OGE2026-07-26
00628725050416Epidural Anesthesia Kit Clint PharmaceuticalsCHS USA Inc.OGE2026-07-21
00628725050300Epidural Anesthesia Kit Clint PharmaceuticalsCHS USA Inc.OGE2026-07-20
00628725050331Epidural Anesthesia Kit Clint PharmaceuticalsCHS USA Inc.OGE2026-07-20
00628725050362Epidural Anesthesia Kit Clint PharmaceuticalsCHS USA Inc.OGE2026-07-20
00628725050379Epidural Anesthesia Kit Clint PharmaceuticalsCHS USA Inc.OGE2026-07-20
00628725050409Epidural Anesthesia Kit Clint PharmaceuticalsCHS USA Inc.OGE2026-07-20
00628725050423Epidural Anesthesia Kit Clint PharmaceuticalsCHS USA Inc.OGE2026-07-20
10198956522015CARDINAL HEALTHCardinal Health 200, LLCOGE2026-07-20
B098AMS11096B0Aligned Medical SolutionsAligned Medical SolutionsOGE2026-07-19
B098AMS188250Aligned Medical SolutionsAligned Medical SolutionsOGE2026-07-19
00628725050232Epidural Anesthesia Kit Clint PharmaceuticalsCHS USA Inc.OGE2026-07-17
00628725050249Epidural Anesthesia Kit Clint PharmaceuticalsCHS USA Inc.OGE2026-07-17
00628725050256Epidural Anesthesia Kit Clint PharmaceuticalsCHS USA Inc.OGE2026-07-17
00628725050270Epidural Anesthesia Kit Clint PharmaceuticalsCHS USA Inc.OGE2026-07-17
00628725050324Epidural Anesthesia KitCHS USA Inc.OGE2026-07-17
B098AMS12381C0Aligned Medical SolutionsAligned Medical SolutionsOGE2026-07-12
10198956460003CARDINAL HEALTHCardinal Health 200, LLCOGE2026-07-09
10198956458529CARDINAL HEALTHCardinal Health 200, LLCOGE2026-07-06
10198956518698CARDINAL HEALTHCardinal Health 200, LLCOGE2026-07-06
10198956466104CARDINAL HEALTHCardinal Health 200, LLCOGE2026-06-08
10198956483255CARDINAL HEALTHCardinal Health 200, LLCOGE2026-06-03
04046955862634Design Options®B. BRAUN MEDICAL INC.OGE2026-06-01
04046955966264Design Options®B. BRAUN MEDICAL INC.OGE2026-06-01
10198956316096CARDINAL HEALTHCardinal Health 200, LLCOGE2026-06-01
00628725050041Epidural Anesthesia KitCHS USA Inc.OGE2025-11-24
00628725050058Epidural Anesthesia KitCHS USA Inc.OGE2025-11-24
00628725050065Epidural Anesthesia KitCHS USA Inc.OGE2025-11-24
10193489431926Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGE2023-06-08
10195594691356CARDINAL HEALTHCardinal Health 200, LLCOGE2023-04-04