AccessGUDID - DEVICE: MABIS (00767056182509)

GUDID

Device Identifier (DI) Information

Brand Name: MABIS
Version or Model: 18-250-000
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 18-250-000
Company Name: D-M-S HOLDINGS, INC.

Primary DI Number: 00767056182509
Issuing Agency: GS1
Commercial Distribution End Date: May 16, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 062028220 *Terms of Use

Device Description: PROBE COVERS FOR PROFESSIONAL EAR THERMOMOMETER (18-200)

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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
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 [?]
K102508	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 703d9d37-54e5-43be-888d-bf0c3e804cd3
Public Version Date: May 17, 2023
Public Version Number: 4
DI Record Publish Date: September 23, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
10767056182506	4	20767056182503	2023-05-16	Not in Commercial Distribution	Master Carton
20767056182503	4	30767056182500	2023-05-16	Not in Commercial Distribution	Intermediate Carton
30767056182500	6	00767056182509	2023-05-16	Not in Commercial Distribution	Inner Carton