← FDA Medical Device Classifications

Insulin Vial Protector/Holder

OJL · Class I — Low Risk (general controls) · Physical Medicine · 21 CFR 890.5050

Classification

FDA Product Code
OJL
Device class
Class I — Low Risk (general controls)
Regulation
21 CFR 890.5050
Review panel
HO
Medical specialty
Physical Medicine
Submission type
4
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N

Definition

The device is intended to protect an insulin vial or vials

Market data

Cleared 510(k) submissions
0
Registered establishments
11

Source

Authoritative
FDA Device Classification database
Machine
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