AccessGUDID - DEVICE: Rapid-i Kit (17350025912230)

GUDID

Device Identifier (DI) Information

Brand Name: Rapid-i Kit
Version or Model: 14421
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Vitrolife Sweden AB

Primary DI Number: 17350025912230
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 20
Labeler D-U-N-S® Number*: 631805488 *Terms of Use

Device Description: No description.

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):	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?
47446	Assisted reproduction vitrification carrier	A sterile, plastic device used during an assisted reproduction vitrification (cryopreservation) procedure to hold a small volume of vitrification media containing a biological specimen (e.g., egg, embryo) to vitrify (cryopreserve) the specimen, thereby avoiding specimen immersion/contact with LN2. The vitrification process may involve the distal tip/specimen being brought into contact with the surface of a vitrification block [a highly-conductive mass of metal semi-submersed in a liquid nitrogen (LN2) bath]. The device with vitrified specimen is then stored in an LN2 tank, and subsequently transferred into a warming medium to recover the specimen. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MQK	Labware, Assisted Reproduction

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K181461	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
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: 0d31f5a0-8acd-41b8-b885-de74e640904e
Public Version Date: January 10, 2023
Public Version Number: 7
DI Record Publish Date: September 13, 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
No Package DIs found

Secondary DI

[?]

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

Unit of Use DI

[?]

Unit of Use DI Number: 07350025912233 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: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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

FDA TOOLS & RESOURCES