FDA.reportPublic FDA data

V. Mueller

Primary DI
70885403008520
Brand
V. Mueller
Company
STERIS CORPORATION
Model
AU5631
Catalog number
AU5631
Device description
V. Mueller ROBERTS COTTON APPLICATORS TRIANGULAR TIP WORKING LENGTH 5 inches 12.7CM
Published
2018-08-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KCJAPPLICATOR, ENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCJApplicator, EntEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
70885403008520PackageGS112In Commercial Distribution
10885403008528PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
7088540300852070885403008520
1088540300852810885403008528

GMDN Terms#

Term, Definition table
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 table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)323-9088Customer_Support@BD.com
+1(800)548-4873xx@xx.xx

Regulatory Flags#

DUNS number
021599373
Device count
12
DM exempt
true
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00724995232016NAX-Ray Table TopBF5532026-05-26
00724995232023NAX-Ray Table TopBF5542026-05-26
00724995232030NATable ExtenderBF5552026-05-26
00724995232054NAX-Ray Table TopBF6622026-05-26
00724995232061NAX-Ray Table TopBF6632026-05-26
00724995232078NAX-Ray Table TopBF6642026-05-26
10724995165250NAX-Ray Table TopBF6632021-04-02
10724995165281NAX-Ray Table TopBF6642021-04-02
10724995245457HexaLuxEXLHAN3EXLHAN32025-05-05
00724995165161NAX-Ray Table TopBF5532021-04-02
00724995165178NATable ExtenderBF5552021-04-02
00724995165185NAX-Ray Table TopBF5542021-04-02
00724995165222NAX-Ray Table TopBF6622021-04-02
10885403018862V. MuellerCD0-3BCD03B2017-11-17
10885403018879V. MuellerCD0-3CCD03C2017-11-17
10885403018893V. MuellerCD0-4BCD04B2017-11-17
10885403018909V. MuellerCD0-4CCD04C2017-11-17
10885403018947V. MuellerCD1-4BCD14B2017-11-17
10885403018954V. MuellerCD1-4CCD14C2017-11-17
10885403018985V. MuellerCD1-5BCD15B2017-11-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00757770410972Bausch + LombBausch & Lomb IncorporatedKCJ2025-07-29
00757770420179Bausch + LombBausch & Lomb IncorporatedKCJ2025-07-29
00757770420766Bausch + LombBausch & Lomb IncorporatedKCJ2025-07-29
00757770427383Bausch + LombBausch & Lomb IncorporatedKCJ2025-07-29
00850027492698NavägeRhinosystems, Inc.KCJ2024-11-15
00887482037898Symmetry FarrellASPEN SURGICAL PRODUCTS, INC.KCJ2024-08-15
00840183517489BR Surgical, LLCBR Surgical, LLCKCJ2024-05-29
04055207009734NARichard Wolf GmbHKCJ2024-05-21
00850022483073Saline Noze MistDr. Noze Best, LLCKCJ2024-02-05
G586E1032750Novo SurgicalNOVO SURGICAL, INC.KCJ2023-12-18
G586E1035960Novo SurgicalNOVO SURGICAL, INC.KCJ2023-12-18
G586E91032250Novo SurgicalNOVO SURGICAL, INC.KCJ2023-12-18
G586E91032270Novo SurgicalNOVO SURGICAL, INC.KCJ2023-12-18
G586E91032290Novo SurgicalNOVO SURGICAL, INC.KCJ2023-12-18
G586E91032750Novo SurgicalNOVO SURGICAL, INC.KCJ2023-12-18
G586E91032770Novo SurgicalNOVO SURGICAL, INC.KCJ2023-12-18
G586E91032790Novo SurgicalNOVO SURGICAL, INC.KCJ2023-12-18
G586E91035460Novo SurgicalNOVO SURGICAL, INC.KCJ2023-12-18
G586E91035960Novo SurgicalNOVO SURGICAL, INC.KCJ2023-12-18
00842331192524Novo Surgical Inc. NOVO SURGICAL, INC.KCJ2023-12-07
05060259070426Sigma SwabMEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITEDKCJ2023-10-05
05060259070488Sigma SwabMEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITEDKCJ2023-10-05
05060259070853DryswabMEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITEDKCJ2023-10-05
05060259070983DryswabMEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITEDKCJ2023-10-05
05060259070990DryswabMEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITEDKCJ2023-10-05
05060259073120DryswabMEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITEDKCJ2023-10-05
05060259073137DryswabMEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITEDKCJ2023-10-05
25060259070420Sigma SwabMEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITEDKCJ2023-10-05
45060259070486Sigma SwabMEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITEDKCJ2023-10-05
25060259070857DryswabMEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITEDKCJ2023-10-05