Primary Device ID | 20817522013388 |
NIH Device Record Key | c8a38d0a-97c8-498b-a78d-318e010aee79 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Swabeze |
Version Model Number | KMI-111 |
Catalog Number | KMI-111 |
Company DUNS | 066175613 |
Company Name | KENTEC MEDICAL, INC. |
Device Count | 50 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | true |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | true |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00817522013384 [Primary] |
GS1 | 10817522013381 [Unit of Use] |
GS1 | 20817522013388 [Package] Contains: 00817522013384 Package: box [300 Units] In Commercial Distribution |
GS1 | 30817522013385 [Package] Package: case [3600 Units] In Commercial Distribution |
KXF | Applicator, Absorbent Tipped, Non-Sterile |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-07-05 |
Device Publish Date | 2024-06-27 |
20817522013340 | low absorption foam swab |
20817522013388 | foam swab |
20817522013364 | foam swab |
20817522013357 | foam swab |
20817522013371 | foam swab |