AccessGUDID - DEVICE: DC Safety (00816058012038)

GUDID

Device Identifier (DI) Information

Brand Name: DC Safety
Version or Model: VFL3Z-19F515-CB
Commercial Distribution Status: In Commercial Distribution
Catalog Number: VFL3Z-19F515-CB
Company Name: DC Safety Sales

Primary DI Number: 00816058012038
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 196527949 *Terms of Use

Device Description: FAK

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: 6a9b61af-4137-47ef-9b12-2eb61dcf9691
Public Version Date: September 16, 2024
Public Version Number: 1
DI Record Publish Date: September 06, 2024