FDA.reportPublic FDA data

NA

Primary DI
50858965006934
Brand
NA
Company
PAJUNK MEDICAL SYSTEMS, LP
Model
TDLS250
Catalog number
NA
Device description
CUSTOM SINGLE SHOT EPIDURAL TRAY Tuohy Epidural 20G x 4"
Published
2025-08-28
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

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
50858965006934PackageGS125In Commercial Distribution
00858965006939PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5085896500693450858965006934
00858965006939008589650069398589650069390858965006939

GMDN Terms#

Term, Definition table
TermDefinition
Epidural anaesthesia set, non-medicatedA collection of devices intended for the administration of an analgesic or anaesthetic agent (not included) to the epidural space for the management of pain. It includes a needle and/or a catheter with additional procedural devices (e.g., syringe, dressings, guidewire, introducer), and may be intended for single- or continuous-administration. It is not intended for intrathecal anaesthesia This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
770-493-6832info@pajunk-usa.com

Regulatory Flags#

DUNS number
136718553
Device count
1
DM exempt
false
Premarket exempt
false
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
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00858965006946NATBL222NA2026-08-07
00858965006939NATDLS250NA2025-08-28
00858965006922NATDLS217NA2025-07-07
50858965006927NATDLS217NA2025-07-07
00858965006892N/ATBL403N/A2025-03-07
00858965006908N/ATBL404N/A2025-03-07
20858965006896N/ATBL403N/A2025-03-07
20858965006902N/ATBL404N/A2025-03-07
00858965006809NATBLU119NA2023-07-13
00858965006878N/ATBL401N/A2024-10-08
00858965006885N/ATBL402N/A2024-10-08
20858965006872N/ATBL401N/A2024-10-08
20858965006889N/ATBL402N/A2024-10-08
00858965006915N/ATDLC211N/A2024-10-07
20858965006919N/ATDLC211N/A2024-10-07
00858965006748NATDLU213NA2023-05-26
00858965006861N/ATDLU205N/A2024-07-15
50858965006866N/ATDLU205N/A2024-07-15
00858965006854N/ATDLU232N/A2024-07-08
50858965006859N/ATDLU232N/A2024-07-08

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