FDA.reportPublic FDA data

SeromaCath

Primary DI
00854373007032
Brand
SeromaCath
Company
GREER MEDICAL, INC.
Model
1035 Pouch
Catalog number
1035
Device description
"Long SeromaCath Wound Drainage System 14G (2,1mm) x 3.5"" (8,9cm)"
Published
2017-05-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GCYApparatus, Suction, Single Patient Use, Portable, Nonpowered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCYApparatus, Suction, Single Patient Use, Portable, NonpoweredGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K905733000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K905733000SEROMA-CATH CLOSE DRAINAGE SYSTEMDawn Medical1991-01-28GCY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00854373007025PackageGS15In Commercial Distribution
00854373007032PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854373007025008543730070258543730070250854373007025
00854373007032008543730070328543730070320854373007032

GMDN Terms#

Term, Definition table
TermDefinition
Closed-wound drain, non-bioabsorbableA tube-like, non-bioabsorbable device designed to establish a channel for the removal of fluid or purulent material from a closed-wound or an infected area, typically used with a closed drainage system that applies a low negative pressure through the drain lumen. It is typically made of silicone and comes in various designs/sizes for a variety of surgical applications (e.g., orthopaedic, plastic/reconstructive, neurological, gynaecological, thoracic, cardiovascular, general surgery). It might include disposable devices dedicated to drain insertion/function (e.g., sharp trocar blade, connector), however it does not include any fluid collection bags/containers. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length3.5Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature50 Degrees Fahrenheit90 Degrees Fahrenheit
Storage Environment Temperature33 Degrees Fahrenheit105 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
805-962-5883info@greer-medical.com

Regulatory Flags#

DUNS number
800169260
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00854373007001SeromaCath1002 Pouch10022017-05-10
00854373007056SeromaCath1275 Pouch12752017-05-10
00854373007025SeromaCath1035 Pouch10352017-05-10
00854373007070Sapphire Suction Reservoir2001 Pouch20012017-05-10
00854373007094SurgiFish4001 Pouch40012017-05-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09420060206036haakaaTHINK GREEN LIMITEDGCY2026-09-20
09420060206043haakaaTHINK GREEN LIMITEDGCY2026-09-20
09420060206050haakaaTHINK GREEN LIMITEDGCY2026-09-20
09420060206067haakaaTHINK GREEN LIMITEDGCY2026-09-20
04710969717906Uresil Evolution PRE.VAC WOUND DRAINAGE BOTTLE 1000 mL, with Connecting TubeCanadian Hospital Specialties LimitedGCY2026-08-18
04710969717913Uresil Evolution PRE.VAC WOUND DRAINAGE BOTTLE 1000 mLCanadian Hospital Specialties LimitedGCY2026-08-18
04710969717920Uresil Evolution Connecting TubeCanadian Hospital Specialties LimitedGCY2026-08-18
04719899159787Uresil Evolution PRE.VAC WOUND DRAINAGE BOTTLE 1000 mLCanadian Hospital Specialties LimitedGCY2026-08-18
04719899159794Uresil Evolution PRE-VAC WOUND DRAINAGE BOTTLECanadian Hospital Specialties LimitedGCY2026-08-18
04719899159824Uresil Evolution Connecting Tube, with SpikeCanadian Hospital Specialties LimitedGCY2026-08-18
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