FDA.reportPublic FDA data

Intravenous-Intraosseous Kit (TMK-IV/IO), Black

Primary DI
00850018892759
Brand
Intravenous-Intraosseous Kit (TMK-IV/IO), Black
Company
Altitude Technologies Inc.
Model
01323BK
Catalog number
01323BK
Device description
The TMK-IV/IO is designed to conveniently house essential intravenous (IV) and intraosseous (IO) infusion supplies and medications for tactical missions.
Published
2020-05-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LRSI.V. Start Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRSI.V. Start KitGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850018892759PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850018892759008500188927598500188927590850018892759

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral intravenous catheterization support kitA collection of noninvasive devices intended to prepare and/or dress a peripheral vein intravenous (IV) access site. It typically includes devices such as a tourniquet, disinfected swabs, dressings, tape, gauze, and gloves; neither the IV access device nor pharmaceuticals are included. It may also include short tubing and/or syringe, however it is not intended to directly conduct fluids from an IV administration bag/bottle (i.e., not an IV administration set). This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850062467170GAP IFAK, RG0213170213172026-01-27
00850062467187GAP IFAK, BK021317BK021317BK2026-01-27
00850062467194GAP IFAK, MC021317MC021317MC2026-01-27
00850062467200GAP IFAK Refill021317REF021317REF2026-01-27
00850062467156Medic Kit (TMK-ME), Black w/SOFTT-W01678BK01678BK2026-01-14
00850062467163Medic Kit (TMK-ME), Black w/CAT01678BK-CAT01678BK-CAT2026-01-14
00850062467149Corpsman Assault Pack Restock0212022025-08-07
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00850062467040GFAK021317PA2024-10-17
00850062467033TMM-FC050062024-10-03
00850062467026Pressure Injury Prevention Kit0213162024-09-18
00850062467002TMM-EDC-L0212302024-03-13
00856767008106FS EZ IO Kit Manual 6PK0211712024-03-13
00856767008045Training TMM-FBT-LTA (Tactical Medical Module-Field Blood Transfusion -Low Titer0211092024-01-18
00856767008007TMM-NPA Naso Airway Module021182024-01-17
00850018892872Chinook IDPA Individual Direct Pressure Adjunct053232023-10-30
00850013417025K9 TECC IFAK, Basic, Black02321BK02321BK2020-05-20
00850013417032K9 TECC IFAK, Basic, OD Green02321OD02321OD2020-05-20
00850013417049K9 TECC IFAK, Basic, Red02321RD02321RD2020-05-20
00850013417056K9 TECC IFAK, Basic, Refill02321REF02321REF2020-05-20

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Primary DI, Brand, Company table
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00810010894984Aero-MedAERO-MED, LLCLRS2026-03-17
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