FDA.report

V. Mueller

Primary DI
10885403108907
Brand
V. Mueller
Company
CAREFUSION 2200, INC
Model
RH205
Catalog number
RH205
Device description
LATHBURY (UEBE) COTTON APPLICATOR TWISTED TIP, LIGHT PATTERN OVERALL LENGTH 7" (17.8CM)
Published
2018-09-10
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
10885403108907PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1088540310890710885403108907

GMDN Terms

TermDefinition
General-purpose absorbent tip applicator/swab, reusableA hand-held manual device in the form of a slender handle made of metal intended to hold an absorbent material such as a cotton pledget at its distal end for cleaning or applying a substance (e.g., medication) to a superficial wound or body orifice, and to take specimens from a patient. It is not dedicated to a particular body area or orifice, and is typically used in a healthcare setting. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800)323-9088Customer_Support@BD.com

Regulatory Flags

DUNS number
832696038
Device count
1
DM exempt
true
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
true

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