AccessGUDID - DEVICE: SDR Vehicle Kit Refill-OTC (M689SDRVSIPOTCREFILL020)

GUDID

Device Identifier (DI) Information

Brand Name: SDR Vehicle Kit Refill-OTC
Version or Model: 2
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SDR-VSIP-OTC
Company Name: Safeguard US Operating, LLC

Primary DI Number: M689SDRVSIPOTCREFILL020
Issuing Agency: HIBCC
Commercial Distribution End Date: June 02, 9999
Device Count: 1
Labeler D-U-N-S® Number*: 118492643 *Terms of Use

Device Description: 31-115 TMT Tourniquet 1.00EA GLOVES-2.00.101 Synmax, Blue, Industrial Grade, Powered Free, Latex Free 1.00 PR 30-212 MARCH Celox Rapid B-CON 3"x2' OTC 1.00EA 11-100-QR-EN POSTIONAL AIRWAY - ENGLISH 2.00 1.00EA L-SDR-VSIP-OTC-REFILSDR Vehicle Kit - OTC-Refill Insert 1.00EA 20-001-KOI Sentinel Chest Seal 2.00 1.00EA FCP-01 ETD 1.00EA BPS-47 Blizzard IFAK 1.00EA 95-000-QR-EN MARCH Cover QR Card - English 1.00EA 31-115-QR-EN TMT - ENGLISH 1.00EA 30-212-QR-EN CELOX RAPID B-CON - ENGLISH 1.00EA 20-001-QR-EN SENTINEL CHEST SEAL - ENGLISH 1.00EA 32-150-QR-EN COMPRESSION DRESSING - ENGLISH 1.00EA 04-101-QR-EN EMERGENCY BLANKET - ENGLISH 1.00EA P81-111 Snap Ring, 1/2" ID, Acetal (.55/13.5mm ID) 1.00EA L01-00 33x1 blank polypropylene TT label 1.00EA P81-250-07 Inner Pouch, PA Kit 7x1 1.00EA P59-100 Inner Pouch, Hypothermia Kit 1.00EA

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:	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?
44047	First aid kit, non-medicated, single-use	A convenient collection of equipment and materials intended to be used in an emergency for the rapid, initial treatment of an injury. This device is typically used by emergency medical services (EMS), institutions, schools, the home, motor vehicles, and other public settings. This device does not contain medicinal substances/pharmaceuticals. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OHO	First Aid Kit Without Drug

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No 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: fb32d032-2c88-4ade-95ef-d5a7b99fd25a
Public Version Date: June 15, 2022
Public Version Number: 1
DI Record Publish Date: June 07, 2022