DataTherm II 501501

GUDID 16148015015013

Lightweight portable continuous temperature monitor used to measure human body temperature and stores temperature readings at preset time intervals. Features on/off, mode access and scrolling feature buttons, special Lock feature for safety, belt clip on back of monitor, features both High and Low adjustable alarm settings, uses 2, 1.5 volt AA batteries, disposable 1M or 2M temperature probes, dimensions (3.16 x 2.37 x .71).

R.G. ENTERPRISES (U.S.A.), INC.

Continuous electronic patient thermometer, battery-powered

• Primary Device ID: 16148015015013
• NIH Device Record Key: adf690e9-544b-408f-9ddc-8480d9f57103
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DataTherm II
• Version Model Number: Datatherm II
• Catalog Number: 501501
• Company DUNS: 928998905
• Company Name: R.G. ENTERPRISES (U.S.A.), 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 248-504-6726
• Email: MaryRN@rgmd.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -14 Degrees Fahrenheit and 140 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00614801150118 [Primary]
GS1	06148015015016 [Primary]
GS1	16148015015013 [Package]; Contains: 00614801150118; Package: Hard Black Case [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070878

FDA Product Code

• FLL: Thermometer, Electronic, Clinical

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-05-07
• Device Publish Date: 2016-09-01

Devices Manufactured by R.G. ENTERPRISES (U.S.A.), INC.

• 16148015015013 - DataTherm II: 2020-05-07Lightweight portable continuous temperature monitor used to measure human body temperature and stores temperature readings at preset time intervals. Features on/off, mode access and scrolling feature buttons, special Lock feature for safety, belt clip on back of monitor, features both High and Low adjustable alarm settings, uses 2, 1.5 volt AA batteries, disposable 1M or 2M temperature probes, dimensions (3.16 x 2.37 x .71).
• 16148015015013 - DataTherm II: 2020-05-07 Lightweight portable continuous temperature monitor used to measure human body temperature and stores temperature readings at pr
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