FDA.reportPublic FDA data

NA

Primary DI
00858965006366
Brand
NA
Company
PAJUNK MEDICAL SYSTEMS, LP
Model
TAL901
Catalog number
NA
Device description
CONTINUOUS EPIDURAL TRAYTuohy Epidural Needle 17G x 4“ withEpiLong Soft Catheter, Closed Tip, 19G
Published
2019-02-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
20858965006360PackageGS110In Commercial Distribution
00858965006366PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2085896500636020858965006360
00858965006366008589650063668589650063660858965006366

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

Contacts#

Phone, Email table
PhoneEmail
888-972-5865xx@xx.xx
770-493-6832info@pajunk-usa.com

Regulatory Flags#

DUNS number
136718553
Device count
1
Kit
true
Combination product
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00858965006939NATDLS250NA2025-08-28
50858965006934NATDLS250NA2025-08-28
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
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
10195594883997CARDINAL HEALTHCardinal Health 200, LLCOGE2022-10-31
10195594856885CARDINAL HEALTHCardinal Health 200, LLCOGE2022-10-27
10195594877187CARDINAL HEALTHCardinal Health 200, LLCOGE2022-10-27
10195594839079CARDINAL HEALTHCardinal Health 200, LLCOGE2022-10-25
10195594853952CARDINAL HEALTHCardinal Health 200, LLCOGE2022-10-20
10195594795320CARDINAL HEALTHCardinal Health 200, LLCOGE2022-10-19