FDA.report

Individual Operator Kit, (TMK-IO), Refill w/SOFTT-W, Contents Only

Primary DI
00850018892247
Brand
Individual Operator Kit, (TMK-IO), Refill w/SOFTT-W, Contents Only
Company
Altitude Technologies Inc.
Model
01274REF
Catalog number
01274REF
Device description
The TMK-IO contains essentials for an individual operator to administer medical attention.
Published
2020-05-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
OHOFirst Aid Kit Without Drug

Product Code Classifications

CodeDeviceSpecialtyClass
OHOFirst Aid Kit Without DrugGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00850018892247PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00850018892247008500188922478500188922470850018892247

GMDN Terms

TermDefinition
First aid kit, non-medicated, single-useA 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.

Sterilization Methods

Method

Contacts

PhoneEmail
800-766-1365sales@chinookmed.com

Regulatory Flags

DUNS number
621904622
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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