FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106655030
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SMA21DPAF1
Catalog number
SMA21DPAF1
Device description
D AND C PACK
Published
2024-05-16
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
PKAExternal upper esophageal sphincter (UES) compression device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PKAExternal Upper Esophageal Sphincter (Ues) Compression DeviceEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50197106655038PackageGS13In Commercial Distribution
10197106655030PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710665503850197106655038
1019710665503010197106655030

GMDN Terms#

Term, Definition table
TermDefinition
Obstetrical/gynaecological surgical procedure kit, non-medicated, single-useA collection of various sterile surgical instruments, dressings/drapes, and materials intended to be used during obstetrical/gynaecological surgery. The kit may be referred to as a procedure pack and is typically comprised of devices that individually are not dedicated to a specific type of obstetrical/gynaecological surgical procedure, but are often supplied together to perform a specific type of obstetrical/gynaecological procedure; it does not contain pharmaceuticals. This is a single-use device.

Regulatory Flags#

DUNS number
961027315
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20885380214377KendallCB2LCB2L2026-10-12
20885380214384KendallCB2LITECB2LITE2026-10-12
20885380214391KendallCB2XLCB2XL2026-10-12
20885380214407KendallCB3LCB3L2026-10-12
20885380214414KendallCB4LCB4L2026-10-12
10192253046397Kendall55535PAMD55535PAMD2023-09-27
10192253046762Kendall55588BAMD55588BAMD2023-10-09
10885380173691Curity6309G6309G2019-11-14
20192253039358Kerlix458845882025-03-19
20192253039365Kerlix50425042-2025-03-19
20192253039372Kerlix61206120-2025-03-19
20192253039396Kerlix507250722025-03-19
20192253039594Kerlix258525852025-03-19
20885380173490Curity2556G2556G2019-11-14
20885380173513Curity2835G2835G2019-11-14
20192253008347CARDINAL HEALTH5005005005002020-09-24
20192253016632Kendall222002A222002A-2024-02-28
20192253016830Kendall30710001307100012024-02-28
20192253017813KendallEF00149EF001492024-02-28
20885380130950MEDI-VAC65652-11965652-1192018-03-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00866736000307Reflux BandThe Reflux CompanyPKA2026-10-08
10197106827376CARDINAL HEALTHCardinal Health 200, LLCPKA2024-12-18
50197106827374CARDINAL HEALTHCardinal Health 200, LLCPKA2024-12-18
10197106743171CARDINAL HEALTHCardinal Health 200, LLCPKA2024-09-26
50197106743179CARDINAL HEALTHCardinal Health 200, LLCPKA2024-09-26
10197106690437CARDINAL HEALTHCardinal Health 200, LLCPKA2024-07-16
50197106690435CARDINAL HEALTHCardinal Health 200, LLCPKA2024-07-16
10197106652015CARDINAL HEALTHCardinal Health 200, LLCPKA2024-06-15
50197106652013CARDINAL HEALTHCardinal Health 200, LLCPKA2024-06-15
50197106655038CARDINAL HEALTHCardinal Health 200, LLCPKA2024-05-16
10197106626474CARDINAL HEALTHCardinal Health 200, LLCPKA2024-04-26
50197106626472CARDINAL HEALTHCardinal Health 200, LLCPKA2024-04-26
10197106524589CARDINAL HEALTHCardinal Health 200, LLCPKA2024-02-29
50197106524587CARDINAL HEALTHCardinal Health 200, LLCPKA2024-02-29
10197106572887CARDINAL HEALTHCardinal Health 200, LLCPKA2024-02-12
50197106572885CARDINAL HEALTHCardinal Health 200, LLCPKA2024-02-12
10197106481875CARDINAL HEALTHCardinal Health 200, LLCPKA2023-12-27
50197106481873CARDINAL HEALTHCardinal Health 200, LLCPKA2023-12-27
10197106293171CARDINAL HEALTHCardinal Health 200, LLCPKA2023-06-23
50197106293179CARDINAL HEALTHCardinal Health 200, LLCPKA2023-06-23
10197106295083CARDINAL HEALTHCardinal Health 200, LLCPKA2023-06-14
50197106295081CARDINAL HEALTHCardinal Health 200, LLCPKA2023-06-14
10197106210567CARDINAL HEALTHCardinal Health 200, LLCPKA2023-05-04
50197106210565CARDINAL HEALTHCardinal Health 200, LLCPKA2023-05-04
10197106191491CARDINAL HEALTHCardinal Health 200, LLCPKA2023-03-29
50197106191499CARDINAL HEALTHCardinal Health 200, LLCPKA2023-03-29