FDA.reportPublic FDA data

Project Lavoy Blood Kit

Primary DI
00850062467019
Brand
Project Lavoy Blood Kit
Company
Altitude Technologies Inc.
Model
021274
Device description
The Project Lavoy Blood Kit is a blood transfusion module (kit) that contains essential items needed to collect and transfuse fresh whole blood in a compact package. The kit is designed to be used by medical personnel in remote and austere environments and does not include vacutainers for follow-up donor testing.
Published
2024-06-19
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
00850062467019PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850062467019008500624670198500624670190850062467019

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.

Regulatory Flags#

DUNS number
621904622
Device count
1
Premarket exempt
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#

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
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
00850018892872Chinook IDPA Individual Direct Pressure Adjunct053232023-10-30
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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M68980820110Valkyrie LTOWB Collection SetSafeguard US Operating, LLCPOQ2024-12-16
00856767008045Training TMM-FBT-LTA (Tactical Medical Module-Field Blood Transfusion -Low TiterAltitude Technologies Inc.POQ2024-01-18
00842209128129NARNORTH AMERICAN RESCUE, LLCPOQ2023-08-10
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M68980801040Fresh Whole Blood Transfusion SetSafeguard US Operating, LLCPOQ2022-10-05
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M68980821060Valkyrie LTOWB Administration SetSafeguard US Operating, LLCPOQ2022-08-22
M68980801050Fresh Whole Blood Transfusion SetSafeguard US Operating, LLCPOQ2022-08-09
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M68980801030Fresh Whole Blood Transfusion SetSafeguard US Operating, LLCPOQ2021-10-01
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M68980820040Valkyrie LTOWB Collection SetSafeguard US Operating, LLCPOQ2021-07-19
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