SwabSleeve™

Primary DI
10887709097107
Brand
SwabSleeve™
Company
ICU MEDICAL, INC.
Model
SCXT3-5-2000
Catalog number
SCXT3-5-2000
Device description
SwabSleeve™
Published
2024-04-05
Public version status
New
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
QBPCap, device disinfectant

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QBPCap, Device DisinfectantGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K130975000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130975000SWABCAP AND SWABFLUSHExcelsior Medical Corp.2013-12-24QBP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20887709097104PackageGS150In Commercial Distribution
30887709097101PackageGS18In Commercial Distribution
10887709097107PrimaryGS10
00887709097100Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2088770909710420887709097104
3088770909710130887709097101
1088770909710710887709097107
00887709097100008877090971008877090971000887709097100

GMDN Terms#

Term, Definition table
TermDefinition
Luer-formatted disinfection capA small, noninvasive, closed-ended Luer attachment intended to be attached to a connector in an intravenous line (e.g., needleless valve, Luer access valve, male Luer connector) to disinfect the valve surface and/or maintain disinfection, and for protection. It is a synthetic polymer cap containing a foam material saturated with isopropyl alcohol (IPA) as the disinfectant; it may contain other components. The cap may be removed shortly after disinfection, or remain in place to maintain disinfection for a limited period. This device may be supplied with male Luer end caps (not containing disinfectant) for use on the disconnected IV tubing. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(866)829-9025customerservice@icumed.com

Regulatory Flags#

DUNS number
118380146
Device count
5
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10887709195131BivonaST26FN50NGF055N2026-06-08
10887709195148BivonaFT25LN30NGF157N2026-06-08
10887709195155BivonaFT26FN35NSF050N2026-06-08
10887709195162BivonaHT26FS45NGF051N2026-06-08
10887709195179BivonaFT26FN40NGF053N2026-06-08
10887709195186BivonaFT26FN35NGF054N2026-06-08
10887709195193BivonaFU26FN45NGF049N2026-06-08
10887709195209BivonaFT26FN60NGA046N2026-06-08
10887709195216BivonaFT26FN35NGE057N2026-06-08
10887709195223BivonaFT26FN30NGE056N2026-06-08
10887709195230BivonaFP26FN40NGC058N2026-06-08
10887709195247BivonaFT26FN35NSF059N2026-06-08
10887709195254BivonaFT26FN40NGE063N2026-06-08
10887709195261BivonaXT26FS60NGC064N2026-06-08
10887709195278BivonaFU26FN45NSF052N2026-06-08
10887709194967BivonaFT26FN40NSF031N2026-06-05
10887709194974BivonaFU26FN35NGF035N2026-06-05
10887709194981BivonaFU26FN40NGE036N2026-06-05
10887709194998BivonaXU26FS35NGA037N2026-06-05
10887709195001BivonaXU26FS35NGA038N2026-06-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
30887709097101SwabSleeve™ICU MEDICAL, INC.QBP2024-04-05
20612479261628McKessonMCKESSON MEDICAL-SURGICAL INC.QBP2022-11-10
20612479261642McKessonMCKESSON MEDICAL-SURGICAL INC.QBP2022-11-10
40612479261639McKessonMCKESSON MEDICAL-SURGICAL INC.QBP2022-11-10
30612479261656McKessonMCKESSON MEDICAL-SURGICAL INC.QBP2022-11-10
00887709097827SwabTip™ICU MEDICAL, INC.QBP2021-08-23
30887709097828SwabTip™ICU MEDICAL, INC.QBP2021-08-23
00887709082151SwabCap™ICU MEDICAL, INC.QBP2021-07-09
00887709082175SwabCap™ICU MEDICAL, INC.QBP2021-07-09
10887709082158SwabCap™ICU MEDICAL, INC.QBP2021-07-09
10887709082172SwabCap™ICU MEDICAL, INC.QBP2021-07-09
10884450309978DualCap®Merit Medical Systems, Inc.QBP2021-05-17
20884450309975DualCap®Merit Medical Systems, Inc.QBP2021-05-17
00382903065974BD PureHubBECTON, DICKINSON AND COMPANYQBP2020-05-08
30382903065968BD PureHubBECTON, DICKINSON AND COMPANYQBP2020-05-08
50382903065962BD PureHubBECTON, DICKINSON AND COMPANYQBP2020-05-08
50382903065979BD PureHubBECTON, DICKINSON AND COMPANYQBP2020-05-08
10884450309459DualCap®Merit Medical Systems, Inc.QBP2020-01-06
20884450309456DualCap®Merit Medical Systems, Inc.QBP2020-01-06
10884450309428DualCap®Merit Medical Systems, Inc.QBP2019-01-16
20884450309425DualCap®Merit Medical Systems, Inc.QBP2019-01-16
10884450309367DualCap®Merit Medical Systems, Inc.QBP2018-09-28
10884450309374DualCap®Merit Medical Systems, Inc.QBP2018-09-28
10884450309411DualCap®Merit Medical Systems, Inc.QBP2018-09-28
20884450309364DualCap®Merit Medical Systems, Inc.QBP2018-09-28
20884450309371DualCap®Merit Medical Systems, Inc.QBP2018-09-28
20884450309418DualCap®Merit Medical Systems, Inc.QBP2018-09-28