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Title 21 Part 880 → Subpart G → §880.6980

Title 21 → Chapter I → Subchapter H → Part 880 → Subpart G → §880.6980

Electronic Code of Federal Regulations e-CFR

Title 21 Part 880 → Subpart G → §880.6980

e-CFR data is current as of July 17, 2019

Title 21Chapter ISubchapter HPart 880Subpart G → §880.6980


Title 21: Food and Drugs
PART 880—GENERAL HOSPITAL AND PERSONAL USE DEVICES
Subpart G—General Hospital and Personal Use Miscellaneous Devices


§880.6980   Vein stabilizer.

(a) Identification. A vein stabilizer is a device consisting of a flat piece of plastic with two noninvasive prongs. The device is placed on the skin so that the prongs are on either side of a vein and hold it stable while a hypodermic needle is inserted into the vein.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in §880.9. If the device is not labeled or otherwise represented as sterile, it is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of §820.180, with respect to general requirements concerning records, and §820.198, with respect to complaint files.

[45 FR 69682, Oct. 21, 1980, as amended at 66 FR 38807, July 25, 2001]