FDA.reportPublic FDA data

Pressure Injury Prevention Kit

Primary DI
00850062467026
Brand
Pressure Injury Prevention Kit
Company
Altitude Technologies Inc.
Model
021316
Device description
The Pressure Injury Prevention Kit contains foam dressings that offer an absorbent, breathable, water-resistent barrier. Minimize the risk of pressure injury formation and pressure related tissue damage by integrating this versatile module into your treatment protocols.
Published
2024-09-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
OHOFirst Aid Kit Without Drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHOFirst Aid Kit Without DrugGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850062467026PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850062467026008500624670268500624670260850062467026

GMDN Terms#

Term, Definition table
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 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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850062467217Fresh Whole Blood Transfusion Kit0204392026-08-27
00850062467224TC3 CLS Kit, CB03895CB2026-08-27
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
00850062467019Project Lavoy Blood Kit0212742024-06-19
00850018892872Chinook IDPA Individual Direct Pressure Adjunct053232023-10-30
00850062467002TMM-EDC-L0212302024-03-13

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