FDA.reportPublic FDA data

Continuous Regional Anesthesia Kit

Primary DI
B875400
Brand
Continuous Regional Anesthesia Kit
Company
Custom Interventional Pain Management, LLC
Model
40
Catalog number
40
Device description
Convenience kit no Lidocaine
Published
2023-07-19
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
OFQAnesthesia Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OFQAnesthesia KitAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B875400PrimaryHIBCC0

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
Ethylene Oxide

Regulatory Flags#

DUNS number
030406006
Device count
1
Premarket exempt
true
Kit
true
Combination product
true
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B875700Individual Ancillary Item Kit70702023-09-11
B87560LID0Discseel60LID60LID2023-08-15
B875DSCLID0DiscseelDSCLIDDSCLID2023-08-15
B875170Epidural Anesthesia Kit17172023-07-19
B87517LID0Epidural Anesthesia Kit17LID17LID2023-07-19
B875180Epidural Anesthesia Kit18182023-07-19
B87518LID0Epidural Anesthesia Kit18LID18LID2023-07-19
B875200Epidural Anesthesia Kit20202023-07-19
B87520LID0Epidural Anesthesia Kit20LID20LID2023-07-19
B875220Epidural Anesthesia Kit22222023-07-19
B87522LID0Epidural Anesthesia Kit22LID22LID2023-07-19
B875300Nerve Block Tray30302023-07-19
B87530LID0Nerve Block Tray30LID30LID2023-07-19
B875310Custom Anesthesia Tray31312023-07-19
B87531LID0Custom Anesthesia Tray31LID31LID2023-07-19
B87534040Bone Access Kit340434042023-07-19
B87540LID0Continuous Regional Anesthesia Kit40LID40LID2023-07-19
B875410Spinal Anesthesia Kit41412023-07-19
B87541LID0Spinal Anesthesia Kit41LID41LID2023-07-19
B875500Refill Tray50502023-07-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
H65857032365Henry ScheinHENRY SCHEIN, INC.OFQ2022-12-12
H65857032105Henry ScheinHENRY SCHEIN, INC.OFQ2022-10-25
H65857032025Henry ScheinHENRY SCHEIN, INC.OFQ2022-09-19
10195594520434CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-09-02
10195594516130CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-07-21
10195594419592CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-05-09
H65857030615Henry ScheinHENRY SCHEIN, INC.OFQ2022-04-29
10195594547585CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-04-06
10195594375423CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-03-15
10195594516338CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-03-15
10195594530839CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-03-15
10195594509859CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-03-14
10195594450717CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-03-10
10195594501136CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-03-07
10195594519902CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-03-07
10195594519919CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-03-07
10195594492106CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-03-01
10195594476199CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-02-26
10195594548438CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-02-24
10195594544065CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-02-21
10195594545475CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-02-21
10195594456221CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-02-15
10195594487225CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-02-11
10195594500009CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-02-10
10195594520601CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-02-10
10195594527860CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-02-10
10195594461188CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-02-08
10195594503772CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-02-07
10195594520533CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-02-07
10195594540340CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-02-07