AccessGUDID - DEVICE: n.a. (04250105601190)

GUDID

Device Identifier (DI) Information

Brand Name: n.a.
Version or Model: 35-40-633
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: VBM Medizintechnik GmbH

Primary DI Number: 04250105601190
Issuing Agency: GS1
Commercial Distribution End Date: May 03, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 324869601 *Terms of Use

Device Description: Fixation Tape

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):	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?
35815	Endotracheal tube holder	A device designed to hold and stabilize an endotracheal (ET) tube when it has been intubated into a patient; it may also include a teeth protector to prevent damage to the teeth or tube during intubation. It typically consists of straps, pinch rings, cloth ties, or Velcro bands and provides the advantage of easy readjustment of the tube without retaping or the use of safety pins. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CBH	Device, Fixation, Tracheal Tube

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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
Special Storage Condition, Specify: keep dry, keep away from sunlight and heat

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Accessory for VBM Endoscopy Mask #3, #5

Device Record Status

Public Device Record Key: b5621587-20e4-44dd-bdfe-b1370c1f9e13
Public Version Date: May 04, 2023
Public Version Number: 2
DI Record Publish Date: September 18, 2020

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
14250105601197	10	04250105601190	2023-05-03	Not in Commercial Distribution

Secondary DI

[?]

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

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found 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: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +49745495960
Email: info@vbm-medical.de

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