SwabCap™

Primary DI
10887709082172
Brand
SwabCap™
Company
ICU MEDICAL, INC.
Model
SCRC3-10-1600
Catalog number
SCRC3-10-1600
Device description
SwabPackPlus™
Published
2021-07-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
10887709082172PackageGS110In Commercial Distribution
00887709082175PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088770908217210887709082172
00887709082175008877090821758877090821750887709082175

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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
118380146
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10887709194967BivonaFT26FN40NSF031N2026-06-05
10887709194974BivonaFU26FN35NGF035N2026-06-05
10887709194981BivonaFU26FN40NGE036N2026-06-05
10887709194998BivonaXU26FS35NGA037N2026-06-05
10887709195001BivonaXU26FS35NGA038N2026-06-05
10887709195018BivonaXU26FS35NGA039N2026-06-05
10887709195025BivonaXU26FS55NGC029N2026-06-05
10887709195032BivonaFT26FN45NSF030N2026-06-05
10887709195049BivonaFU26FN60NSA032N2026-06-05
10887709195056BivonaFT26FN25NGE033N2026-06-05
10887709195063BivonaFT26FN30NGE034N2026-06-05
10887709195070BivonaHT26FS70NSC042N2026-06-05
10887709195087BivonaSU26FN35NGF041N2026-06-05
10887709195094BivonaFT26FN30NGF045N2026-06-05
10887709195100BivonaFT26FN25NGF044N2026-06-05
10887709195117BivonaFA26FN70NSC047N2026-06-05
10887709195124BivonaFU26FN70NTC048N2026-06-05
10887709194899BivonaFU26FN35NGE024N2026-06-04
10887709194905BivonaFT26FN40NGE027N2026-06-04
10887709194912BivonaFU26FN40NGE028N2026-06-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10887709097107SwabSleeve™ICU MEDICAL, INC.QBP2024-04-05
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
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