AccessGUDID - DEVICE: BRAUN (00328785000313)

GUDID

Device Identifier (DI) Information

Brand Name: BRAUN
Version or Model: PC20NAFFV1
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: KAZ USA, INC.

Primary DI Number: 00328785000313
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 20
Labeler D-U-N-S® Number*: 122612547 *Terms of Use

Device Description: Braun ThermoScan PC20 Probe Covers, for use with PRO3000 and PRO4000 series thermometers. This package contains 20 probe covers. Not for resale. The probe cover is intended for use as a sanitary barrier between the thermometer and ear canal.

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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
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 [?]
K103800	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: 80cc89f7-cfeb-48fb-96cd-ba92fea1bbd6
Public Version Date: May 27, 2020
Public Version Number: 4
DI Record Publish Date: August 29, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
40328785000311	10	00328785000313	In Commercial Distribution	Inner
60328785000315	25	40328785000311	In Commercial Distribution	Case
50328785000318	4	40328785000311	In Commercial Distribution	Case