AccessGUDID - DEVICE: Novo Vivo (00736239051000)

GUDID

Device Identifier (DI) Information

Brand Name: Novo Vivo
Version or Model: 05100
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 05100
Company Name: Genesis Industries, Incorporated

Primary DI Number: 00736239051000
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 157053026 *Terms of Use

Device Description: Novo Vivo Suction Catheter

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:	Yes
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?
30882	Assisted reproduction transfer catheter trial	A flexible polymer tube intended to be used to simulate the transvaginal insertion of an assisted reproduction catheter set for embryo transfer, to assess advancement through the cervical canal and the position of the uterus. It typically consists of an inner and outer catheter (or catheter sheath) identical to the devices used for the transfer procedure, except that the inner catheter has a rounded blind/closed distal end. This device cannot be used for the introduction of embryos or other reproductive materials into the cervical canal or uterine cavity. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GBS	Catheter, Ventricular, General & Plastic Surgery

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7ccb3e56-7449-4235-8c99-0a6f1c97f38b
Public Version Date: September 20, 2023
Public Version Number: 1
DI Record Publish Date: September 12, 2023

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

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: No
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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