FDA.reportPublic FDA data

Aligned Medical Solutions

Primary DI
B098AMS198620
Brand
Aligned Medical Solutions
Company
Aligned Medical Solutions
Model
AMS19862
Catalog number
AMS19862
Device description
Epidural Pack - RX
Published
2026-08-31
Public version status
Update
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
B098AMS198621PackageHIBCC20In Commercial Distribution
B098AMS198620PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Epidural anaesthesia set, medicatedA collection of devices intended for the administration of an analgesic or anaesthetic agent to the epidural space for the management of pain. It includes the pharmaceutical anaesthetic agent and a needle, with additional devices utilized for the procedure (e.g., syringe, dressings), and may include a catheter (i.e., may be intended for single- or continuous-administration). It is not intended for intrathetcal 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
B098AMS12206A0Aligned Medical SolutionsAMS12206AAMS12206A2026-09-18
B098AMS16321B0Aligned Medical SolutionsAMS16321BAMS16321B2026-09-18
B098AMS17151B0Aligned Medical SolutionsAMS17151BAMS17151B2026-09-18
B098AMS187250Aligned Medical SolutionsAMS18725AMS187252026-09-18
B098AMS189300Aligned Medical SolutionsAMS18930AMS189302026-09-18
B098AMS193700Aligned Medical SolutionsAMS19370AMS193702026-09-18
B098AMS194470Aligned Medical SolutionsAMS19447AMS194472026-09-18
B098AMS195520Aligned Medical SolutionsAMS19552AMS195522026-09-18
B098AMS195590Aligned Medical SolutionsAMS19559AMS195592026-09-18
B098AMS195760Aligned Medical SolutionsAMS19576AMS195762026-09-18
B098AMS196360Aligned Medical SolutionsAMS19636AMS196362026-09-02
B098AMS196370Aligned Medical SolutionsAMS19637AMS196372026-09-18
B098AMS196590Aligned Medical SolutionsAMS19659AMS196592026-09-18
B098AMS197450Aligned Medical SolutionsAMS19745AMS197452026-09-18
B098AMS197460Aligned Medical SolutionsAMS19746AMS197462026-09-18
B098AMS197470Aligned Medical SolutionsAMS19747AMS197472026-09-18
B098AMS197480Aligned Medical SolutionsAMS19748AMS197482026-09-18
B098AMS197520Aligned Medical SolutionsAMS19752AMS197522026-09-18
B098AMS197680Aligned Medical SolutionsAMS19768AMS197682026-09-18
B098AMS7712B0Aligned Medical SolutionsAMS7712BAMS7712B2026-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956542853CARDINAL HEALTHCardinal Health 200, LLCOGE2026-09-04
10198956560369CARDINAL HEALTHCardinal Health 200, LLCOGE2026-09-04
10198956561847CARDINAL HEALTHCardinal Health 200, LLCOGE2026-09-04
10198956563155CARDINAL HEALTHCardinal Health 200, LLCOGE2026-09-04
10198956564343CARDINAL HEALTHCardinal Health 200, LLCOGE2026-09-04
10198956564619CARDINAL HEALTHCardinal Health 200, LLCOGE2026-09-04
10198956565227CARDINAL HEALTHCardinal Health 200, LLCOGE2026-09-04
10198956366107CARDINAL HEALTHCardinal Health 200, LLCOGE2026-08-18
10198956551411CARDINAL HEALTHCardinal Health 200, LLCOGE2026-08-18
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
10198956530218CARDINAL HEALTHCardinal Health 200, LLCOGE2026-07-27
10198956530270CARDINAL HEALTHCardinal Health 200, LLCOGE2026-07-27
10198956531253CARDINAL HEALTHCardinal Health 200, LLCOGE2026-07-27
10198956531482CARDINAL HEALTHCardinal Health 200, LLCOGE2026-07-27
10198956533110CARDINAL HEALTHCardinal Health 200, LLCOGE2026-07-27
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