FDA.reportPublic FDA data

Grafco

Primary DI
M36832141
Brand
Grafco
Company
GF HEALTH PRODUCTS, INC.
Model
3214
Catalog number
3214
Device description
URINAL FEMALE PLASTIC BLUE
Published
2021-06-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
FNPUrinal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FNPUrinalGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M36832141PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held urinal, reusableA portable, hand-held container intended to be directly urinated into by a patient for excretory purposes; it may be specific to male or female patients, or unisex. It is typically in the form of a bottle with a handle, or a bag, or pouch; it may include a noninvasive funnel and tubing, and may have a drain with a stopper in it to facilitate emptying. It is not intended to be worn by the patient. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
770-368-4700cs@grahamfield.com

Regulatory Flags#

DUNS number
132016168
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M368EPC500ST1HAUSTEDEPC500ST2026-04-09
M368EPC500STMB1HAUSTEDEPC500ST-MB2026-04-09
M3681097001GRAHAM FIELD109-7002026-02-20
M36812731Grafco127312732020-10-01
M36812751Grafco127512752020-10-01
M3684001GF1GRAFCO4001GF4001GF2020-04-01
M3684002GF1GRAFCO4002GF4002GF2020-04-01
M3682362X1GRAHAM FIELD2362X2026-02-20
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00748426261819Medline-MicrotekMicrotek Medical LLCFNP2026-01-28
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00748426261840Medline-MicrotekMicrotek Medical LLCFNP2026-01-28
00748426261857Medline-MicrotekMicrotek Medical LLCFNP2026-01-28
00748426261864Medline-MicrotekMicrotek Medical LLCFNP2026-01-28
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20748426261752Medline-MicrotekMicrotek Medical LLCFNP2026-01-28
20748426261769Medline-MicrotekMicrotek Medical LLCFNP2026-01-28
20748426261776Medline-MicrotekMicrotek Medical LLCFNP2026-01-28
20748426261783Medline-MicrotekMicrotek Medical LLCFNP2026-01-28
20748426261790Medline-MicrotekMicrotek Medical LLCFNP2026-01-28
20748426261806Medline-MicrotekMicrotek Medical LLCFNP2026-01-28
20748426261813Medline-MicrotekMicrotek Medical LLCFNP2026-01-28
20748426261820Medline-MicrotekMicrotek Medical LLCFNP2026-01-28
20748426261837Medline-MicrotekMicrotek Medical LLCFNP2026-01-28
20748426261844Medline-MicrotekMicrotek Medical LLCFNP2026-01-28
20748426261851Medline-MicrotekMicrotek Medical LLCFNP2026-01-28
20748426261868Medline-MicrotekMicrotek Medical LLCFNP2026-01-28
20748426261875Medline-MicrotekMicrotek Medical LLCFNP2026-01-28
20748426261882Medline-MicrotekMicrotek Medical LLCFNP2026-01-28