DEVICE: Emergency Medical Products (00851772007069)
Device Identifier (DI) Information
Emergency Medical Products
IFAK2-B
In Commercial Distribution
EMERGENCY MEDICAL PRODUCTS, INC.
IFAK2-B
In Commercial Distribution
EMERGENCY MEDICAL PRODUCTS, INC.
IFAK Officer Down Kit w/Back Pouch
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
Yes | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
58058 | Plant polysaccharide haemostatic agent, non-bioabsorbable, antimicrobial |
A non-bioabsorbable device derived from plant polysaccharides [e.g., micro-dispersed oxidized cellulose (M-Doc), oxidized regenerated cellulose (ORC)] that contains an antimicrobial agent to help prevent infection, intended for topical application to a traumatic wound (e.g., abrasion, laceration, cut), ulcer, and/or surgical wound, to facilitate local haemostasis. It is available in various forms (e.g., gel, spray, ointment) that can be applied directly to the wound where it forms a seal until removed. It is intended for use in the home or healthcare facility. This is a single-use device.
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Active | false |
35844 | Limb tourniquet, manual, reusable |
A strap or tubing intended to be wrapped around a patient's limb (arm or leg) and manually tightened to reduce blood circulation to or from the portion of the limb distal to where the device is applied. It is typically used by emergency medical services (EMS) for emergency blood loss prevention or for routine blood sampling. It will typically have a fastening mechanism (e.g., Velcro or a self-locking buckle) that allows adjustments to the degree of tightness. This is a reusable device which may be intended for single- or multi-patient use.
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Obsolete | false |
34864 | Adhesive bandage |
A sterile piece of fabric or plastic material intended to be applied to a part of a patient's body and held in place by its pressure-sensitive adhesive to secure objects to the skin, cover and protect wounds, and/or approximate the skin edges of a wound; it may or may not include an absorbent pad. It is not intended for compression bandaging and is not an adhesive tape nor an adhesive strip (e.g., such as an Elastoplast or Band-aid brand). This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
LMG | Agent, absorbable hemostatic, non-collagen based |
OJS | Tourniquet kit |
OVR | Kit, first aid, talking |
OPA | Powder-free non-natural rubber latex surgeon's gloves |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
12d69040-342b-479e-9950-84cd93afb933
June 10, 2022
6
September 24, 2016
June 10, 2022
6
September 24, 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 |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined