FDA UDI In Commercial Distribution 🇺🇸 United States

SDR Vehicle Kit Refill-OTC

DI: M689SDRVSIPOTCREFILL020 · Model: 2 · Safeguard US Operating, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
SDR Vehicle Kit Refill-OTC
Primary DI
M689SDRVSIPOTCREFILL020
Version / Model
2
Catalog Number
SDR-VSIP-OTC
Company Name
Safeguard US Operating, LLC
Labeler DUNS
118492643
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2022-06-07
Public Version
1
Public Version Date
2022-06-15
Public Version Status
New
Public Device Record Key
fb32d032-2c88-4ade-95ef-d5a7b99fd25a
Distribution End Date
9999-06-02

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

Single Use
Yes
Prescription Use (Rx)
No
Over the Counter (OTC)
Yes
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
Yes
PM Exempt
No
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
OHO First Aid Kit Without Drug

GMDN Terms

Code Name
44047 First aid kit, non-medicated, single-use

Identifiers

Type ID
Primary M689SDRVSIPOTCREFILL020