FDA.reportPublic FDA data

Training TMM-FBT-LTA (Tactical Medical Module-Field Blood Transfusion -Low Titer

Primary DI
00856767008045
Brand
Training TMM-FBT-LTA (Tactical Medical Module-Field Blood Transfusion -Low Titer
Company
Altitude Technologies Inc.
Model
021109
Device description
Blood transfusion kit
Published
2024-01-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
POQBlood Transfusion Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
POQBlood Transfusion KitGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00856767008045PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856767008045008567670080458567670080450856767008045

GMDN Terms#

Term, Definition table
TermDefinition
Blood transfusion set, non-exchangeAn intravascular administration set intended to be used to administer blood from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device typically includes a needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, a stopcock, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an intravenous (IV) bag or other infusion fluid container. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
621904622
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

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Primary DIBrandModelCatalogPublished
00850062467170GAP IFAK, RG0213170213172026-01-27
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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
00850018892834My PAK, Adult (Personal Aid Kit), Black02805BK02805BK2020-06-10
00856767008359My PAK, Adult (Personal Aid Kit), Red02805RD02805RD2020-05-19
00850018892858My PAK, (Personal Aid Kit), Child, Black02803BK02803BK2020-08-11
00856767008366My PAK, Child02803RD02803RD2020-05-19
00850062467149Corpsman Assault Pack Restock0212022025-08-07
00850062467132Universal Stylette Bougie Assisted Cricothyrotomy (USBCR)0215552025-08-04
00850062467040GFAK021317PA2024-10-17
00850062467033TMM-FC050062024-10-03
00863970000469TMM-FC (Tactical Medical Module - Foley Catheter)50062018-05-15
00850062467026Pressure Injury Prevention Kit0213162024-09-18
00850062467019Project Lavoy Blood Kit0212742024-06-19
00850018892872Chinook IDPA Individual Direct Pressure Adjunct053232023-10-30
00850062467002TMM-EDC-L0212302024-03-13
00856767008106FS EZ IO Kit Manual 6PK0211712024-03-13

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Primary DI, Brand, Company table
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