120ML/53MM SPCW/LBL,NTL CAP,ST
Sterile Specimen Container - 010038
Device Description
An empty covered receptacle containing no additives or media intended to be used for the collection, and preservation and/or transport, of more than one type of clinical specimen (e.g., urine, faeces, sputum, mucous, tissue) derived from different body regions 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
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: True
Sterilization Methods:
- Radiation Sterilization
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
Device IdentifiersDevice Id: 37503025060027
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 57503025060021
Package Quantity: 4
Package Discontinue Date: 7/28/2022 12:00:00 AM
Package Status: Not in Commercial Distribution
Package Type: Case
Device Id: 17503025060023
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
Device Id: 57503025060021
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 17503025060023
Package Quantity: 75
Package Discontinue Date: 7/28/2022 12:00:00 AM
Package Status: Not in Commercial Distribution
Package Type: PACKAGE