HEPRO.US - MM 1000 Test Strips Case

GUDID 00850578007389

Case/Carton of 425 boxes of 50 TEST STRIPS HEPRO.US MM1000 - the FDA number is 3012098689 - the operator number is 10049962

HEPRO.US INC.

Glucose monitoring system IVD, home-use

• Primary Device ID: 00850578007389
• NIH Device Record Key: 518a5675-29c1-4efe-a8d3-f5e1a47fd4aa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HEPRO.US - MM 1000 Test Strips Case
• Version Model Number: Hepro.usTSC
• Company DUNS: 080061451
• Company Name: HEPRO.US INC.
• Device Count: 21250
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: true
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850578007389 [Primary]
GS1	85057800738902 [Unit of Use]

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-06-02

Devices Manufactured by HEPRO.US INC.

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• 00850578007600 - HEPRO.US Blood Collection Sets with Pre-Attached Holder: 2019-10-23 Blood Collection Sets with Pre-Attached Holder Single 23G x 3/4 x 12"
• 00850578007617 - Hepro.us - Case of 10 Boxes of Blood collection sets with pre-attached hold: 2019-10-23 Case of 10 Boxes of Blood collection sets with pre-attached holder
• 00854427007018 - HEPRO.US - Needle Pen Tip 1 Box 100pcs: 2019-10-23 Insulin Pen Needle Sterile Single Use Pen Needle 31G 0.25x 6m. Fits most Insulin Pens 100pcs per 1 Box
• 00854427007056 - HEPRO.US Standard Surgical Gown Case: 2019-10-23 Material 68gsm A/S Spunlace Includes 2 hand paper towels 30.5 x 34 cm and 1 Wrapper - 40 Sterile Pouch
• 00854427007063 - HEPRO.US Reinforced Surgical Gown Case 43gsm: 2019-10-23 Material 43gsm A/S SMMS Includes 2 hand paper towels 30.5 x 34 cm and 1 Wrapper - 50 Sterile Pouch - Case
• 00854427007841 - HEPRO.US Standard Surgical Gown L 43gsm 1 Pouch: 2019-10-23 Standard Surgical Gown L 1 Pouch 43gsm A/S SMMS, with two hand paper towels and wrapper, EO Sterile
• 00854427007858 - HEPRO.US Reinforced Surgical Gown L 43gsm: 2019-10-23 Reinforced Surgical Gown L 1 Pouch 43gsm SMMS