FDA.report

G Series NP12 Mattress Family

Primary DI
00845699004362
Brand
G Series NP12 Mattress Family
Company
SIZEWISE RENTALS, L.L.C.
Model
G Series NP12 Mattress Family
Published
2021-03-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
FNMMattress, Air Flotation, Alternating Pressure

Product Code Classifications

CodeDeviceSpecialtyClass
FNMMattress, Air Flotation, Alternating PressureGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00845699004362PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00845699004362008456990043628456990043620845699004362

GMDN Terms

TermDefinition
Alternating-pressure bed mattressA mattress-like device consisting of an arrangement of alternating-pressure air cells designed to be placed on a bed mattress support platform to provide a comfortable surface on which an occupant can lie, rest, and sleep, and intended to distribute body weight over a large surface area typically to help relieve pressure points for comfort and improve blood circulation to prevent pressure sores. It is connected to an alternating-pressure pump (not included) which provides the inflation/deflation control. It is commonly used for elderly immobilized (especially in cases of decubitus ulcers) patients, patients with disabilities, or patients with low body fat.

Sterilization Methods

Method

Contacts

PhoneEmail
951-273-7888jcastro@sizewisemfg.com

Regulatory Flags

DUNS number
967025602
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00845699002412SizewiseBT39862024-09-20
00845699002429SizewiseBT48862024-09-20
00845699002436SizewiseMA39862024-09-20
00845699002443SizewiseMA48862024-09-20
00845699002450SizewiseBPUL 39862024-09-20
00845699002474SizewiseNP126 39802024-09-20
00845699002481SizewiseNP126 42802024-09-20
00845699002498SizewiseNP12G 3948802024-09-20
00845699002504SizewiseNPT3 G 39802024-09-20
00845699002511SizewiseNPT3 G 42802024-09-20
00845699002528SizewiseNPT3 G 48802024-09-20
00845699002535SizewiseNPT3 G 3948802024-09-20
00845699002597SizewiseENVY NPT335882024-09-20
00845699002603SizewiseENVY NP935882024-09-20
00845699002610SizewiseADP 35882024-09-20
00845699002627SizewiseADP PLAT35882024-09-20
00845699002634SizewiseADP LAL35882024-09-20
00845699002641SizewiseADP PULLAL35882024-09-20
00845699002658SizewiseADP ROLAL35882024-09-20
00845699002672SizewiseIMLAL 35802024-09-20

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
04719893356922WellellWellell Inc.FNM2026-03-20
00860013391003ThinAIRTHIN AIR SURFACES, LLCFNM2026-03-10
00860013391010ThinAIRTHIN AIR SURFACES, LLCFNM2026-03-10
00860013391027ThinAIRTHIN AIR SURFACES, LLCFNM2026-03-10
00860013391034ThinAIRTHIN AIR SURFACES, LLCFNM2026-03-10
00860013391041ThinAIRTHIN AIR SURFACES, LLCFNM2026-03-10
00810178887040ViveVIVE HEALTH LLCFNM2026-03-06
00810178887057ViveVIVE HEALTH LLCFNM2026-03-06
H93392270Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNM2026-02-25
04719893356540WellellWellell Inc.FNM2026-02-11
00810178884193ViveVIVE HEALTH LLCFNM2026-02-02
00810178884483ViveVIVE HEALTH LLCFNM2026-01-30
05059441536024AtmosAir VelarisArjohuntleigh ABFNM2026-01-15
05059441536031AtmosAir VelarisArjohuntleigh ABFNM2026-01-15
05059441536048AtmosAir VelarisArjohuntleigh ABFNM2026-01-15
05059441536055AtmosAir VelarisArjohuntleigh ABFNM2026-01-15
05059441536062AtmosAir VelarisArjohuntleigh ABFNM2026-01-15
05059441536079AtmosAir VelarisArjohuntleigh ABFNM2026-01-15
08592654544112OPTICAREL I N E T spol. s r.o.FNM2026-01-07
00860014621895Thrive MedicalSupply Line MedicalFNM2025-12-26
00860015100412Thrive MedicalSupply Line MedicalFNM2025-12-26
00860015100429Thrive MedicalSupply Line MedicalFNM2025-12-26
04719873698608NACARILEX MEDICAL, INC.FNM2025-12-22
04719873698615NACARILEX MEDICAL, INC.FNM2025-12-22
14719873698629NACARILEX MEDICAL, INC.FNM2025-12-22
14719873698636NACARILEX MEDICAL, INC.FNM2025-12-22
05061105057455Protekt VX 5000PROACTIVE MEDICAL PRODUCTS, LLCFNM2025-12-18
10193489148305MEDLINEMEDLINE INDUSTRIES, INC.FNM2025-12-12
10197344066100MEDLINEMEDLINE INDUSTRIES, INC.FNM2025-12-12
10197344172856MEDLINEMEDLINE INDUSTRIES, INC.FNM2025-12-12