CARDINAL HEALTH · AMM1956
AERO-MED, LLC · PSA and Testosterone Kit
Open FDA's page for this record- Has donation ID number
- false
- Mri safety
- Labeling does not contain MRI Safety Information
- Record status
- Published
- Is labeled as nrl
- false
- Is rx
- false
- Commercial distribution status
- In Commercial Distribution
- Device description
- PSA and Testosterone Kit
- Public device record key
- 3cbbfe65-97db-41ec-86a3-e935b0b9904c
- Has serial number
- false
- Public version date
- 2026-05-15
- Is direct marking exempt
- false
- Public version number
- 2
- Labeler duns number
- 194550042
- Is labeled as no nrl
- true
- Is single use
- true
- Is otc
- true
- Version or model number
- AMM1956
- Has manufacturing date
- false
- Brand name
- CARDINAL HEALTH
- Is combination product
- false
- Is kit
- true
- Device count in base package
- 1
- Is pm exempt
- true
- Has lot or batch number
- true
- Catalog number
- AMM1956
- Company name
- AERO-MED, LLC
- Public version status
- Update
- Has expiration date
- true
- Is hct p
- false
- Publish date
- 2019-04-26
- Sterilization
- Is sterile
- false
- Is sterilization prior use
- false
- Identifiers
- ID
- 10810010891355
- Type
- Primary
- Issuing agency
- GS1
- Product codes
- Code
- OIB
- Name
- Blood and urine collection kit (excludes HIV testing)
- Harmonized identifiers (openFDA)
- Device name
- Blood And Urine Collection Kit (Excludes Hiv Testing)
- Medical specialty description
- Pathology
- Regulation number
- 864.3250
- Device class
- 1
- Gmdn terms
- Code
- 18026
- Name
- Phlebotomy kit
- Implantable
- false
- Code status
- Active
- Definition
A collection of devices and supplies used in the practice of collecting blood samples. It typically consists of test tubes, racks, needles, bandages, gauze pads, and a sharps container. This is a single-use device.