AccessGUDID - DEVICE: Adview (00634782564650)

GUDID

Device Identifier (DI) Information

Brand Name: Adview
Version or Model: 9000TP
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 9000TP
Company Name: AMERICAN DIAGNOSTIC CORP

Primary DI Number: 00634782564650
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 500
Labeler D-U-N-S® Number*: 108999095 *Terms of Use

Device Description: Adview Probe Covers, 500/tray,20/box, 25 boxes/tray

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	Yes
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
13116	Electronic thermometer probe cover	A device intended to be used as a physical barrier between the patient and the probe of a thermometer that uses electronics to create the measurement, e.g., a tympanic (in-the-ear) or electronic (body) thermometer, to prevent cross-contamination between patients. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FLL	Thermometer, Electronic, Clinical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K070750	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Humidity: between 15 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between -4 and 131 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: aa5aa366-c5d5-4cf7-a960-27ba04d111c6
Public Version Date: August 31, 2018
Public Version Number: 1
DI Record Publish Date: July 31, 2018

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
00634782065201	10	00634782564650		In Commercial Distribution	Master

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: 00634782094539 CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 1-800-232-2670
Email: info@adctoday.com

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