APLICARE APL82280S

GUDID 30197344007039

JELLY, LUBE, STERILE, FOIL PACK, 3G

MEDLINE INDUSTRIES, INC.

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• Primary Device ID: 30197344007039
• NIH Device Record Key: 351e2a22-ef2a-464c-93e6-30d6ec1ebb6d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: APLICARE
• Version Model Number: APL82280S
• Catalog Number: APL82280S
• Company DUNS: 025460908
• Company Name: MEDLINE INDUSTRIES, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)633-5463
• Email: service@medline.com
• Phone: +1(800)633-5463
• Email: service@medline.com
• Phone: +1(800)633-5463
• Email: service@medline.com
• Phone: +1(800)633-5463
• Email: service@medline.com
• Phone: +1(800)633-5463
• Email: service@medline.com
• Phone: +1(800)633-5463
• Email: service@medline.com
• Phone: +1(800)633-5463
• Email: service@medline.com
• Phone: +1(800)633-5463
• Email: service@medline.com
• Phone: +1(800)633-5463
• Email: service@medline.com
• Phone: +1(800)633-5463
• Email: service@medline.com
• Phone: +1(800)633-5463
• Email: service@medline.com
• Phone: +1(800)633-5463
• Email: service@medline.com
• Phone: +1(800)633-5463
• Email: service@medline.com
• Phone: +1(800)633-5463
• Email: service@medline.com
• Phone: +1(800)633-5463
• Email: service@medline.com
• Phone: +1(800)633-5463
• Email: service@medline.com
• Phone: +1(800)633-5463
• Email: service@medline.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry. Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry. Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry. Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry. Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry. Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry. Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry. Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry. Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry. Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry. Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry. Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry. Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry. Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry. Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry. Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry. Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry. Keep away from sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	10197344007035 [Primary]
GS1	30197344007039 [Package]; Contains: 10197344007035; Package: CS [1000 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K912132

FDA Product Code

• FHX: JELLY, LUBRICATING, FOR TRANSURETHRAL SURGICAL INSTRUMENT

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-01-31
• Device Publish Date: 2024-01-23

On-Brand Devices [APLICARE]

• 00618407611066: SWABSTCK,BENZOIN TINCTURE,SINGLE, STRL
• 00618407611103: SWABSTICK,SKIN,PROTECTOR,PREPSITE
• 00618407410102: PAD,PREP,SKIN PROTECTANT,STERILE
• 20618407631051: SWAB STICK,ALCOHOL3PK,STERILE
• 20618407611053: SWABSTICK,ALCOHOL,SINGLES,BULK,1000/
• 30197344007046: LUBRICATING JELLY PACKET, STERILE, 5
• 30197344007039: JELLY, LUBE, STERILE, FOIL PACK, 3G