Container, Specimen, Non-sterile

Device Code: 2796

Product Code(s): NNI

Device Classification Information

• Device Type ID: 2796
• Device Name: Container, Specimen, Non-sterile
• Regulation Description: Specimen Transport And Storage Container.
• Regulation Medical Specialty: Pathology
• Review Panel: General Hospital
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID); General Hospital Devices Branch (GHDB)
• Submission Type: 510(K) Exempt
• CFR Regulation Number: 864.3250 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: NNI
• GMP Exempt: Yes
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

• Device Type ID: 2796
• Device: Container, Specimen, Non-sterile
• Product Code: NNI
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Specimen Transport And Storage Container.
• CFR Regulation Number: 864.3250 [🔎]

Recalls
Manufacturer		Recall Class	Date Posted
1	Dynarex Corporation	II	Jun-28-2016

TPLC Last Update: 2019-04-02 20:18:57