AccessGUDID - DEVICE: n.a. (04250105608304)

GUDID

Device Identifier (DI) Information

Brand Name: n.a.
Version or Model: 56-01-050
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: VBM Medizintechnik GmbH

Primary DI Number: 04250105608304
Issuing Agency: GS1
Commercial Distribution End Date: August 16, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 324869601 *Terms of Use

Device Description: Dispo Infusor for single use

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?
13100	Intravenous pressure infusor, manual, reusable	A manually-operated device designed to increase/control the rate of an intravenous (IV) solution given to a patient by manually applying pressure directly to the infusion bag. It is typically a flexible inflatable bag/cuff with a pocket to hold the infusion bag; it may include a squeeze bulb, mechanical screw, or spring mechanism to create the pressure. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KZD	Infusor, Pressure, For I.V. Bags

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: for rapid pressure infusion and irrigation purposes
Total Volume: 500 Milliliter

Device Record Status

Public Device Record Key: d631bfc1-fd3e-42de-b7fa-246f4c534de3
Public Version Date: August 17, 2023
Public Version Number: 3
DI Record Publish Date: August 31, 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
14250105608301	5	04250105608304	2023-08-16	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

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES