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
New
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
General surgical procedure kit, non-medicated, single-useA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. 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
false
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
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
00628725050270Epidural Anesthesia Kit Clint PharmaceuticalsCPT20SCPT20S2026-07-17
00628725050003Nerve Block TrayCPT11CPT112025-11-20
00628725050058Epidural Anesthesia KitCPT4CPT42025-11-24
00628725050010Nerve Block TrayCPT11SPCPT11SP2025-11-20
00628725050041Epidural Anesthesia KitCPT10ATCPT10AT2025-11-24
00628725050065Epidural Anesthesia KitCPT4EXCPT4EX2025-11-24
00628725095363Pleural Drain Dry Seal System H03100H031002026-04-17
00628725095370Pleural Drain Wet Seal System H03004H030042026-04-17
00628725095318Micro Minimuffs0403420403422026-01-07
50628725095313Micro Minimuffs0403420403422026-01-07
50628725050046Epidural Anesthesia KitCPT10ATCPT10AT2025-11-24
50628725050053Epidural Anesthesia KitCPT4CPT42025-11-24
50628725050060Epidural Anesthesia KitCPT4EXCPT4EX2025-11-24
00628725050027Nerve Block TrayCPT114CPT1142025-11-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10198956518698CARDINAL HEALTHCardinal Health 200, LLCOGE2026-07-06
B098AMS10930A0Aligned Medical SolutionsAligned Medical SolutionsOGE2026-07-03
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
10195594804459CARDINAL HEALTHCardinal Health 200, LLCOGE2023-01-25
10195594890018CARDINAL HEALTHCardinal Health 200, LLCOGE2023-01-19
10195594766177CARDINAL HEALTHCardinal Health 200, LLCOGE2023-01-17
10195594869885CARDINAL HEALTHCardinal Health 200, LLCOGE2022-12-23
10195594877330CARDINAL HEALTHCardinal Health 200, LLCOGE2022-12-21
10195594679170CARDINAL HEALTHCardinal Health 200, LLCOGE2022-12-15
10195594839109CARDINAL HEALTHCardinal Health 200, LLCOGE2022-12-14
10195594879273CARDINAL HEALTHCardinal Health 200, LLCOGE2022-11-29
10195594840907CARDINAL HEALTHCardinal Health 200, LLCOGE2022-11-10