FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956316096
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
34PAIN06C
Catalog number
34PAIN06C
Device description
SNGL SHT 18G EPI FLTR NDL TRAY
Published
2026-06-01
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
50198956316094PackageGS110In Commercial Distribution
10198956316096PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895631609450198956316094
1019895631609610198956316096

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, medicatedA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, and that includes a pharmaceutical component, 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Regulatory Flags#

DUNS number
961027315
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10192253067958Dover200620062026-01-15
10192253067965Dover61536153-2026-01-15
10192253067972Dover61546154-2026-01-15
10192253067989Dover812281222026-01-15
10192253067996Dover888760078488876007842026-01-15
10192253068009Dover89498949-2026-01-15
10192253068016Dover895089502026-01-15
10192253068702Dover888760077688876007762026-01-16
10192253071405CARDINAL HEALTHALMASK5ALMASK52026-04-06
10192253071412CARDINAL HEALTHAMMASK4AMMASK42026-03-23
10192253071429CARDINAL HEALTHAXLMASK6AXLMASK62026-03-23
10192253071436CARDINAL HEALTHCHIMASK3CHIMASK32026-03-23
10192253071443CARDINAL HEALTHINFMASK1INFMASK12026-03-23
10192253071450CARDINAL HEALTHNEOMASK0NEOMASK02026-03-23
10192253071467CARDINAL HEALTHTODMASK2TODMASK22026-03-23
10192253006278Genius3030963030962024-02-28
10192253006285Genius3030973030972024-02-28
10192253047486Telfa766776672025-09-08
10197106917619CARDINAL HEALTHPC15OT92CPC15OT92C2026-07-20
10198956119505CARDINAL HEALTHSVA35VCBLCSVA35VCBLC2026-07-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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
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