FDA.report

MEDICOM SAFEBASICS

Primary DI
20686864053822
Brand
MEDICOM SAFEBASICS
Company
AMD Medicom Inc
Model
803
Catalog number
803
Device description
MEDICOM SAFEBASICS SWABS 3 In Cotton Tip
Published
2019-01-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
KXFAPPLICATOR, ABSORBENT TIPPED, NON-STERILE

Product Code Classifications

CodeDeviceSpecialtyClass
KXFApplicator, Absorbent Tipped, Non-SterileGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
12686864053823PackageGS110Not in Commercial Distribution
20686864053822PackageGS110In Commercial Distribution
30686864053829PackageGS110In Commercial Distribution
10686864053825PrimaryGS10
00686864053828Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1268686405382312686864053823
2068686405382220686864053822
3068686405382930686864053829
1068686405382510686864053825
00686864053828006868640538286868640538280686864053828

GMDN Terms

TermDefinition
General-purpose absorbent tip applicator/swab, single-useA hand-held manual device, also known as a cotton bud or swab, in the form of a stick with a single- or double-ended absorbent tip (e.g., cotton pledget), intended for cleaning or applying a substance (e.g., medication) to a superficial wound or body orifice, and/or to take specimens from a patient. It is not dedicated to a particular body area or orifice, and is intended for use in a healthcare setting and/or in the home. This is a single-use device.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Room temperature
Storage Environment Humidity080 Percent (%) Relative Humidity

Sterilization Methods

Method

Contacts

PhoneEmail
+1(514)636-6262mdasilva@medicom.ca

Regulatory Flags

DUNS number
256880576
Device count
100
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
true
Sterilization required before use
false

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