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
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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 and is not intended to measure urine output. This is a reusable device.

Contacts#

Phone, Email table
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
true
Serial number
false
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M36811331LUMISCOPE11332016-08-31
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

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
00748426261871Medline-MicrotekMicrotek Medical LLCFNP2026-01-28
00748426261888Medline-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