FDA.report

S-Vac® Perforated Drain

Primary DI
00840113200702
Brand
S-Vac® Perforated Drain
Company
ASPEN SURGICAL PRODUCTS, INC.
Model
340006
Device description
Intended used for closed wound suction drainage
Published
2021-02-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
GCYAPPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED

Product Code Classifications

CodeDeviceSpecialtyClass
GCYApparatus, Suction, Single Patient Use, Portable, NonpoweredGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840113200702PackageGS110In Commercial Distribution
00840113200696PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840113200702008401132007028401132007020840113200702
00840113200696008401132006968401132006960840113200696

GMDN Terms

TermDefinition
Closed-wound drainage kitA collection of devices designed to remove fluids or purulent material from a closed-wound in a controlled manner. It includes a container (the receptacle or reservoir), drains/catheters, connectors, a grasping device and possibly a trocar for placing the drains/catheters into the site. The reservoir will usually be provided with graduated markers along its side to facilitate the approximate measurement of the collected fluids. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(616)698-7100customerservice@aspensurgical.com

Regulatory Flags

DUNS number
027680821
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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