FDA.reportPublic FDA data

Epidural Anesthesia Kit

Primary DI
00628725050058
Brand
Epidural Anesthesia Kit
Company
CHS USA Inc.
Model
CPT4
Catalog number
CPT4
Device description
Needle Stick Pad, Syringe, Luer Lock, needle, L.O.R. Syringe, Drape, adhesive fen, Towel, PVP Triple Swab sticks, Gauze Sponge, Wrap
Published
2025-11-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
50628725050053PackageGS130In Commercial Distribution
00628725050058PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5062872505005350628725050053
00628725050058006287250500586287250500580628725050058

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
Premarket exempt
true
Kit
true
Combination product
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00628725095363Pleural Drain Dry Seal System H03100H031002026-04-17
00628725095370Pleural Drain Wet Seal System H03004H030042026-04-17
00628725095318Micro Minimuffs0403420403422026-01-07
50628725095313Micro Minimuffs0403420403422026-01-07
00628725050041Epidural Anesthesia KitCPT10ATCPT10AT2025-11-24
00628725050065Epidural Anesthesia KitCPT4EXCPT4EX2025-11-24
50628725050046Epidural Anesthesia KitCPT10ATCPT10AT2025-11-24
50628725050053Epidural Anesthesia KitCPT4CPT42025-11-24
50628725050060Epidural Anesthesia KitCPT4EXCPT4EX2025-11-24
00628725050027Nerve Block TrayCPT114CPT1142025-11-21
00628725050003Nerve Block TrayCPT11CPT112025-11-20
00628725050010Nerve Block TrayCPT11SPCPT11SP2025-11-20
00628725050034Nerve Block TrayCPT116CPT1162025-11-20
50628725050008Nerve Block TrayCPT11CPT112025-11-20
50628725050015Nerve Block TrayCPT11SPCPT11SP2025-11-20
50628725050039Nerve Block TrayCPT116CPT1162025-11-20

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Primary DI, Brand, Company table
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