FDA.reportPublic FDA data

Epidural Anesthesia Kit

Primary DI
00628725050324
Brand
Epidural Anesthesia Kit
Company
CHS USA Inc.
Model
CPT4SP
Catalog number
CPT4SP
Device description
SINGLE SHOT EPIDURAL TRAY
Published
2026-07-17
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

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
50628725050329PackageGS130In Commercial Distribution
00628725050324PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5062872505032950628725050329
00628725050324006287250503246287250503240628725050324

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.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
118995594
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00628725050218Clint Pharmaceuticals SINGLE SHOT EPIDURAL TRAYCPT10CPT102026-08-07
00628725050225Clint Pharmaceuticals SINGLE SHOT EPIDURAL TRAYCPT10SPCPT10SP2026-08-07
00628725050317Clint Pharmaceuticals SINGLE SHOT EPIDURAL TRAYCPT5SPGCPT5SPG2026-08-07
00628725050348Clint Pharmaceuticals SINGLE SHOT EPIDURAL TRAYCPT6SP45CPT6SP452026-08-07
00628725050386Clint Pharmaceuticals SINGLE SHOT EPIDURAL TRAYCPT7SPGCPT7SPG2026-08-07
00628725050416Epidural Anesthesia Kit Clint PharmaceuticalsCPT7CPT72026-07-21
00628725050287Nerve Block Tray Clint PharmaceuticalsCPT22Q45CPT22Q452026-07-20
00628725050294Nerve Block Tray Clint PharmaceuticalsCPT25Q35CPT25Q352026-07-20
00628725050300Epidural Anesthesia Kit Clint PharmaceuticalsCPT3CPT32026-07-20
00628725050331Epidural Anesthesia Kit Clint PharmaceuticalsCPT5CPT52026-07-20
00628725050362Epidural Anesthesia Kit Clint PharmaceuticalsCPT5SPCPT5SP2026-07-20
00628725050379Epidural Anesthesia Kit Clint PharmaceuticalsCPT6CPT62026-07-20
00628725050409Epidural Anesthesia Kit Clint PharmaceuticalsCPT6SPCPT6SP2026-07-20
00628725050423Epidural Anesthesia Kit Clint PharmaceuticalsCPT7SPCPT7SP2026-07-20
00628725050188Nerve Block TrayCPT110CPT1102026-07-17
00628725050195Nerve Block TrayCPT11CHCPT11CH2026-07-17
00628725050201Nerve Block TrayCPT11KCCPT11KC2026-07-17
00628725050232Epidural Anesthesia Kit Clint PharmaceuticalsCPT17SPGCPT17SPG2026-07-17
00628725050249Epidural Anesthesia Kit Clint PharmaceuticalsCPT18LCPT18L2026-07-17
00628725050256Epidural Anesthesia Kit Clint PharmaceuticalsCPT20LCPT20L2026-07-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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
B098AMS12381C0Aligned Medical SolutionsAligned Medical SolutionsOGE2026-07-12
10198956460003CARDINAL HEALTHCardinal Health 200, LLCOGE2026-07-09
10198956458529CARDINAL HEALTHCardinal Health 200, LLCOGE2026-07-06