Para
Para-Pak EcoFix / Clean - 301312
Device Description
A covered receptacle containing transport buffer solution or microbiological medium (e.g., Carey-Blair transport medium) intended to be used for the collection, preservation, and transport of a faecal specimen for in vitro diagnostic investigation. It does not contain patient-contact specimen sampling/extraction devices such as swabs/brushes. This is a single-use device.
Environmental Conditions
- 30.00
- 15.00
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: FMH
Device Name: Container, Specimen, Sterile
Device Class: 1
Physical State: N/A
Definition: N/A
Submission Type ID: 4
Review Panel: HO
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 864.3250
Third Party Flag: N
Medical Specialty: PA
Code: LDX
Device Name: Fixative, Metallic Containing
Device Class: 1
Physical State: N/A
Definition: N/A
Submission Type ID: 4
Review Panel: PA
Review Code: N/A
Technical Method: Y
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 864.4010
Third Party Flag: N
Medical Specialty: PA
Device IdentifiersDevice Id: 00840733102622
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A