FDA.report

SIMMONS Clinical Care

Primary DI
M368765000SP2
Brand
SIMMONS Clinical Care
Company
GF HEALTH PRODUCTS, INC.
Model
765000SP
Device description
Clinical Sensor Plus Alternating Pressure Pump
Published
2016-08-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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
M368765000SP2PackageHIBCC4In Commercial Distribution
M368765000SP1PrimaryHIBCC0

GMDN Terms

TermDefinition
Alternating-pressure pumpAn electrically-powered device that forces ambient air into the parallel chambers of an alternating-pressure bed mattress overlay or an alternating-pressure chair cushion, for the timed alternation of chamber inflation and thereby exchange of patient contact points. The pump, which may be programmable, ensures a regular exchange of the overlay/cushion pressure points for the patient.

Storage And Handling

TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-15 Degrees Celsius50 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
770-368-4700cs@grahamfield.com

Regulatory Flags

DUNS number
132016168
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
M3681097002GRAHAM FIELD109-7002026-02-20
M3682338A1GRAHAM FIELD2338A 2026-02-20
M3682338X1GRAHAM FIELD2338X2026-02-20
M36823452A1GRAHAM FIELD2345-2A2026-02-20
M36823452C1GRAHAM FIELD2345-2C 2026-02-20
M36823452X1GRAHAM FIELD2345-2X2026-02-20
M36823481A1GRAHAM FIELD2348-1A 2026-02-20
M36823552N1GRAHAM FIELD2355-2N 2026-02-20
M36823552X1GRAHAM FIELD2355-2X 2026-02-20
M36823562A1GRAHAM FIELD2356-2A 2026-02-20
M36823562C1GRAHAM FIELD2356-2C 2026-02-20
M36823562N1GRAHAM FIELD2356-2N 2026-02-20
M36823562X1GRAHAM FIELD2356-2X 2026-02-20
M36823572A1GRAHAM FIELD2357-2A 2026-02-20
M3682360A1GRAHAM FIELD2360A 2026-02-20
M3682362X2GRAHAM FIELD2362X2026-02-20
M368ESC2EYESTMBX1HAUSTEDESC2EYEST-MB-X2026-02-02
M368H0678972HAUSTEDH0678972025-10-31
M368ALX361AMERILUXALX362025-12-11
M368ALX421AMERILUXALX422025-12-11

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00817012031881K-0 ECO-ZONEKAP MEDICALFNM2026-05-26
00817012031898K-0 ECO-ZONEKAP MEDICALFNM2026-05-26
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