Swabeze KMI-LA

GUDID 20817522013340

low absorption foam swab

KENTEC MEDICAL, INC.

General-purpose absorbent tip applicator/swab, single-use General-purpose absorbent tip applicator/swab, single-use General-purpose absorbent tip applicator/swab, single-use General-purpose absorbent tip applicator/swab, single-use General-purpose absorbent tip applicator/swab, single-use General-purpose absorbent tip applicator/swab, single-use General-purpose absorbent tip applicator/swab, single-use General-purpose absorbent tip applicator/swab, single-use General-purpose absorbent tip applicator/swab, single-use General-purpose absorbent tip applicator/swab, single-use General-purpose absorbent tip applicator/swab, single-use General-purpose absorbent tip applicator/swab, single-use General-purpose absorbent tip applicator/swab, single-use General-purpose absorbent tip applicator/swab, single-use

• Primary Device ID: 20817522013340
• NIH Device Record Key: 0ee0cf00-b68b-49a5-86a4-e31a9c2a1687
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Swabeze
• Version Model Number: KMI-LA
• Catalog Number: KMI-LA
• Company DUNS: 066175613
• Company Name: KENTEC MEDICAL, INC.
• Device Count: 1
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	10817522013343 [Primary]
GS1	20817522013340 [Package]; Contains: 10817522013343; Package: box [300 Units]; In Commercial Distribution
GS1	30817522013347 [Package]; Package: case [3600 Units]; In Commercial Distribution

FDA Product Code

• KXF: Applicator, Absorbent Tipped, Non-Sterile

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-06-28
• Device Publish Date: 2024-06-20

Devices Manufactured by KENTEC MEDICAL, INC.

• 20817522013340 - Swabeze: 2024-06-28low absorption foam swab
• 20817522013340 - Swabeze: 2024-06-28 low absorption foam swab
• 20817522010356 - Ameritus: 2024-06-06 large size ecg electrode
• 20817522010363 - Ameritus: 2024-06-06 small size ecg electrode
• 20817522013333 - Kentec electrode: 2024-05-03 5-lead electrode
• 10817522010663 - Ameritus Transducer: 2022-11-28 transducer
• 10817522010670 - Ameritus Transducer: 2022-11-28 transducer
• 10817522010687 - Ameritus Transducer: 2022-11-28 transducer
• 10817522010694 - Ameritus Transducer: 2022-11-28 transducer