DEVICE: Emergency Medical Products (00851772007069)

Device Identifier (DI) Information

Emergency Medical Products
IFAK2-B
In Commercial Distribution

EMERGENCY MEDICAL PRODUCTS, INC.
00851772007069
GS1

1
061738290 *Terms of Use
IFAK Officer Down Kit w/Back Pouch
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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.
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.
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.
Active false
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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
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FDA Premarket Submission

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

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

12d69040-342b-479e-9950-84cd93afb933
June 10, 2022
6
September 24, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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