FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50197106697151
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
34-4016A
Catalog number
34-4016A
Device description
CERVICAL PAIN TRAY
Published
2024-08-12
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
PVVParacervical Anesthesia Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PVVParacervical Anesthesia KitObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50197106697151PackageGS136In Commercial Distribution
10197106697153PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710669715150197106697151
1019710669715310197106697153

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral anaesthesia single-administration set, medicatedA collection of devices intended for the single-administration of an anaesthetic agent to function as a peripheral nerve-block. It includes a pharmaceutical anaesthetic agent with an anaesthesia needle and a syringe often with additional devices utilized for the procedure (e.g., dressings); as a single-administration set it does not include a catheter. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

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
10197106911266CARDINAL HEALTHSBA60POLHCSBA60POLHC2026-06-08
10197106983577CARDINAL HEALTHSEN69ERMVDSEN69ERMVD2026-06-08
10198956182264CARDINAL HEALTHSCV43OOTGKSCV43OOTGK2026-06-08
10198956218611CARDINAL HEALTHSOP55AOKFJSOP55AOKFJ2026-06-08
10198956227552CARDINAL HEALTHSEY33EPCAFSEY33EPCAF2026-06-08
10198956279391CARDINAL HEALTH01-0111A01-0111A2026-06-08
10198956312920CARDINAL HEALTHSMA57CESARSMA57CESAR2026-06-08
10198956332096CARDINAL HEALTHSOP32THGMLSOP32THGML2026-06-08
10198956336865CARDINAL HEALTHPN73CRKPBPN73CRKPB2026-06-08
10198956343139CARDINAL HEALTHSOP45HAOCCSOP45HAOCC2026-06-08
10198956359024CARDINAL HEALTHSBA24UPJRGSBA24UPJRG2026-06-08
10198956362932CARDINAL HEALTHSEN48TASABSEN48TASAB2026-06-08
10198956364349CARDINAL HEALTHSBACGRPGRASBACGRPGRA2026-06-08
10198956364783CARDINAL HEALTHSNE38LMCIBSNE38LMCIB2026-06-08
10198956373372CARDINAL HEALTHSOP31EXHNGSOP31EXHNG2026-06-08
10198956373976CARDINAL HEALTHSOP38SHUSHSOP38SHUSH2026-06-08
10198956374119CARDINAL HEALTHSBA56LPSTCSBA56LPSTC2026-06-08
10198956386150CARDINAL HEALTHSEN69SPREBSEN69SPREB2026-06-08
10198956387171CARDINAL HEALTHSBA41PLRSESBA41PLRSE2026-06-08
10198956390430CARDINAL HEALTHSEN37TSPSDSEN37TSPSD2026-06-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956426337CARDINAL HEALTHCardinal Health 200, LLCPVV2026-03-26
10198956404540CARDINAL HEALTHCardinal Health 200, LLCPVV2026-03-09
50198956404548CARDINAL HEALTHCardinal Health 200, LLCPVV2026-03-09
10197106841105CARDINAL HEALTHCardinal Health 200, LLCPVV2025-01-09
50197106841103CARDINAL HEALTHCardinal Health 200, LLCPVV2025-01-09
10197106841112CARDINAL HEALTHCardinal Health 200, LLCPVV2025-01-07
50197106841110CARDINAL HEALTHCardinal Health 200, LLCPVV2025-01-07
10197106697153CARDINAL HEALTHCardinal Health 200, LLCPVV2024-08-12
10197106686812CARDINAL HEALTHCardinal Health 200, LLCPVV2024-07-08
50197106686810CARDINAL HEALTHCardinal Health 200, LLCPVV2024-07-08
10197106664636CARDINAL HEALTHCardinal Health 200, LLCPVV2024-06-21
10197106664643CARDINAL HEALTHCardinal Health 200, LLCPVV2024-06-21
50197106664634CARDINAL HEALTHCardinal Health 200, LLCPVV2024-06-21
50197106664641CARDINAL HEALTHCardinal Health 200, LLCPVV2024-06-21
10197106518168CARDINAL HEALTHCardinal Health 200, LLCPVV2024-04-10
50197106518166CARDINAL HEALTHCardinal Health 200, LLCPVV2024-04-10
10197106518175CARDINAL HEALTHCardinal Health 200, LLCPVV2024-03-14
50197106518173CARDINAL HEALTHCardinal Health 200, LLCPVV2024-03-14
10195327540951Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PVV2023-12-21
10195327543686Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PVV2023-12-21
40195327540952Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PVV2023-12-21
40195327543687Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PVV2023-12-21
10197106404096CARDINAL HEALTHCardinal Health 200, LLCPVV2023-10-04
50197106404094CARDINAL HEALTHCardinal Health 200, LLCPVV2023-10-04
10195327424046Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PVV2023-06-04
40195327424047Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PVV2023-06-04
10195327344009Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PVV2023-04-02
40195327344000Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PVV2023-04-02
10195327338619Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PVV2023-02-12
40195327338610Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PVV2023-02-12