AccessGUDID - DEVICE: Kia (00816058012311)

GUDID

Device Identifier (DI) Information

Brand Name: Kia
Version or Model: R0F73 AU000
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: R0F73 AU000
Company Name: DC Safety Sales

Primary DI Number: 00816058012311
Issuing Agency: GS1
Commercial Distribution End Date: November 30, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 196527949 *Terms of Use

Device Description: First Aid Kit Small

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):	Yes
Kit:	Yes
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?
12500	Medical bag	A portable, durable, hand-held container of plastic, fabric, or leather designed for transportation of small medical devices, instruments, and/or supplies. It typically includes attachments for easy handling and mechanisms for closure and/or locking; it may have the internal space appropriately configured according to the intended contents (e.g., stethoscopes, sphygmomanometers, drugs). It may be dedicated for a variety of purposes and/or users, including specialization for physicians, nurses, first aid providers, or paramedics. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LRR	First Aid Kit With Drug

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: d381e637-9d0b-45a7-b440-7680e8d97aad
Public Version Date: November 30, 2023
Public Version Number: 4
DI Record Publish Date: October 07, 2022

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
10816058012318	1	00816058012311	2023-11-30	Not in Commercial Distribution	Bag
20816058012315	12	10816058012318	2023-11-30	Not in Commercial Distribution	case
30816058012312	12	10816058012318	2023-11-30	Not in Commercial Distribution	case (bagged)