FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50888439459843
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
34-2808A
Catalog number
34-2808A
Device description
PARACERVICAL PUDENDAL BLK KIT
Published
2019-06-12
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
50888439459843PackageGS110In Commercial Distribution
10888439459845PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088843945984350888439459843
1088843945984510888439459845

GMDN Terms#

Term, Definition table
TermDefinition
Cervical anaesthesia kitA collection of sterile devices designed to deliver an analgesic or anaesthetic agent to function as an intracervical nerve-block and/or a paracervical regional nerve-block (sometimes including uterosacral and pudendal regions). It is typically used for gyneacological diagnostic tests such as dilation and curettage, small excisional procedures such as endometrial biopsy, or for pain management during labour and/or delivery. It typically consists of a procedural needle, syringe, catheter, and a filter. This is a single-use device.

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
10192253004649Monoject8602RC8602RC2026-07-09
10192253004656Monoject8605RC8605RC2026-07-09
10192253004663Monoject8607RC8607RC2026-07-09
10192253004700Monoject8617RC8617RC2026-07-09
10192253051575Precision2650SA2650SA2026-07-09
10197106896327CARDINAL HEALTHSNENU0868BSNENU0868B2026-07-09
10198956074668CARDINAL HEALTHSBA37OTMOFSBA37OTMOF2026-07-09
10198956119260CARDINAL HEALTHSBA69MPSUBSBA69MPSUB2026-07-09
10198956119437CARDINAL HEALTHPVVMVPBLGPVVMVPBLG2026-07-09
10198956255586CARDINAL HEALTHSOP53SAPTHSOP53SAPTH2026-07-09
10198956268272CARDINAL HEALTHSMA54CSWMMSMA54CSWMM2026-07-09
10198956286719CARDINAL HEALTHSOT11BR10MSOT11BR10M2026-07-09
10198956307308CARDINAL HEALTHSAN43ADSWOSAN43ADSWO2026-07-09
10198956313576CARDINAL HEALTHSMA69BTDNBSMA69BTDNB2026-07-09
10198956333888CARDINAL HEALTHPBCGLSARGPBCGLSARG2026-07-09
10198956334373CARDINAL HEALTHSNECGBPNODSNECGBPNOD2026-07-09
10198956339132CARDINAL HEALTHSEYHDCAGWHSEYHDCAGWH2026-07-09
10198956345942CARDINAL HEALTHSANOCIRHTBSANOCIRHTB2026-07-09
10198956349834CARDINAL HEALTHSAN73PLCHMSAN73PLCHM2026-07-09
10198956360358CARDINAL HEALTHSCV73VPBHDSCV73VPBHD2026-07-09

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
50197106697151CARDINAL 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