FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50197106832613
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SNE48LMCO4
Catalog number
SNE48LMCO4
Device description
SPINE PACK
Published
2024-11-13
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
OAAAid, visual, for nausea

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OAAAid, Visual, For NauseaUnknownN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50197106832613PackageGS13In Commercial Distribution
10197106832615PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710683261350197106832613
1019710683261510197106832615

GMDN Terms#

Term, Definition table
TermDefinition
Ice bagA flexible container (a bag) designed to be filled with ice to provide dry cold therapy to a limited external surface area of the body. It is typically made of plastic or rubber materials with a detachable cap that can be threaded or fixed to the bag once it is filled with ice. It may include a holder or attachments to facilitate fixing or holding the device in place against the body surface of the patient. It can be used to alleviate pain and/or promote healing in minor injuries of the body, e.g., after minor surgery, bruises, tissue swelling, or for application around the neck or limbs. This is a reusable 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
10192253047981Kendall923692362026-06-09
10192253047998Kendall923892382026-06-09
10192253048001Kendall923992392026-06-09
10192253048018Kendall924092402026-06-09
10192253048025Kendall924292422026-06-09
10192253048032Kendall924392432026-06-09
10192253046205Webcol511051102024-09-05
10192253047066Webcol68186818-2025-06-10
10192253047073Webcol6818-16818-12025-07-28
10884521008427Dover502750272016-09-24
10885380052538CARDINAL HEALTHC-CB2SC-CB2S2023-08-07
10885380052545CARDINAL HEALTHC-CB3SC-CB3S2023-08-07
10885380052569CARDINAL HEALTHC-CB6SC-CB6S2023-08-07
10885380052613CARDINAL HEALTHC-CB6C-CB62023-08-07
10885380107801CARDINAL HEALTHABP1201ABP12012016-07-22
10885380107818CARDINAL HEALTHASC1201ASC12012016-07-22
10885380107825CARDINAL HEALTHASC1210ASC12102016-07-22
10885380107832CARDINAL HEALTHASC1211ASC12112016-07-22
10885380107849CARDINAL HEALTHASC1220ASC12202016-07-22
10885380107856CARDINAL HEALTHASC1221ASC12212016-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956101845CARDINAL HEALTHCardinal Health 200, LLCOAA2025-06-10
10198956102095CARDINAL HEALTHCardinal Health 200, LLCOAA2025-06-10
10198956110205CARDINAL HEALTHCardinal Health 200, LLCOAA2025-06-10
50198956101843CARDINAL HEALTHCardinal Health 200, LLCOAA2025-06-10
50198956102093CARDINAL HEALTHCardinal Health 200, LLCOAA2025-06-10
50198956110203CARDINAL HEALTHCardinal Health 200, LLCOAA2025-06-10
10198956101296CARDINAL HEALTHCardinal Health 200, LLCOAA2025-06-05
10198956101418CARDINAL HEALTHCardinal Health 200, LLCOAA2025-06-05
50198956101294CARDINAL HEALTHCardinal Health 200, LLCOAA2025-06-05
50198956101416CARDINAL HEALTHCardinal Health 200, LLCOAA2025-06-05
10197106908792CARDINAL HEALTHCardinal Health 200, LLCOAA2025-01-02
50197106908790CARDINAL HEALTHCardinal Health 200, LLCOAA2025-01-02
10197106824443CARDINAL HEALTHCardinal Health 200, LLCOAA2024-12-23
10197106835340CARDINAL HEALTHCardinal Health 200, LLCOAA2024-12-23
50197106824441CARDINAL HEALTHCardinal Health 200, LLCOAA2024-12-23
50197106835348CARDINAL HEALTHCardinal Health 200, LLCOAA2024-12-23
10197106876275CARDINAL HEALTHCardinal Health 200, LLCOAA2024-12-20
10197106866498CARDINAL HEALTHCardinal Health 200, LLCOAA2024-12-11
50197106866496CARDINAL HEALTHCardinal Health 200, LLCOAA2024-12-11
10197106825150CARDINAL HEALTHCardinal Health 200, LLCOAA2024-12-06
50197106825158CARDINAL HEALTHCardinal Health 200, LLCOAA2024-12-06
10197106852248CARDINAL HEALTHCardinal Health 200, LLCOAA2024-12-04
10197106859025CARDINAL HEALTHCardinal Health 200, LLCOAA2024-12-04
50197106852246CARDINAL HEALTHCardinal Health 200, LLCOAA2024-12-04
50197106859023CARDINAL HEALTHCardinal Health 200, LLCOAA2024-12-04
10197106810248CARDINAL HEALTHCardinal Health 200, LLCOAA2024-11-25
50197106810246CARDINAL HEALTHCardinal Health 200, LLCOAA2024-11-25
10197106721049CARDINAL HEALTHCardinal Health 200, LLCOAA2024-11-15
50197106721047CARDINAL HEALTHCardinal Health 200, LLCOAA2024-11-15
10197106796108CARDINAL HEALTHCardinal Health 200, LLCOAA2024-11-13