FDA.reportPublic FDA data

Capette™

Primary DI
10889483228579
Brand
Capette™
Company
SUNMED, LLC
Model
CP-4201
Catalog number
CP-4201
Device description
Small Capette™ with Small Tube Tackles
Published
2025-12-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JAYSupport, Breathing Tube

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JAYSupport, Breathing TubeAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20889483228576PackageGS140In Commercial Distribution
00709078012990PreviousGS10
10889483228579PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2088948322857620889483228576
00709078012990007090780129907090780129900709078012990
1088948322857910889483228579

GMDN Terms#

Term, Definition table
TermDefinition
Medical/surgical interventional tube/cable securement strapA strip of material in the form of tape/strap intended to be used to secure interventional patient tubes/cables to drapes or device covers in surgical/medical settings; it is not intended to attach to the patient and has no additional intended uses. It may be comprised of, e.g., an adhesive on one side to allow attachment to a drape/cover and Velcro on the other side for securing tubing/cables. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
1-800-433-2797info@sun-med.com

Regulatory Flags#

DUNS number
069009268
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10889483564134BALLARD™216-5216-52026-07-09
10889483563113BALLARD™11000110002025-12-01
10889483007051SunMed9-0207-019-0207-012024-03-12
10889483007068SunMed9-0207-039-0207-032024-03-12
10889483564325BALLARD™2210-52210-52025-11-20
10889483623411BALLARD™22056-522056-52025-11-20
10889483221747AirLife™026202622025-12-19
10889483222157Ambu900-000-601900-000-6012025-12-19
10889483222164Ambu900-000-602900-000-6022025-12-19
10889483222188Ambu900-000-604900-000-6042025-12-19
10889483222195Ambu900-000-605900-000-6052025-12-19
10889483222201Ambu900-000-606900-000-6062025-12-19
10889483222225Ambu900-000-609900-000-6092025-12-19
10889483222232Ambu900-000-611900-000-6112025-12-19
10889483231494Ambu900-000-614900-000-6142025-12-19
10889483231524Ambu900-000-617900-000-6172025-12-19
10889483231531Ambu900-000-618900-000-6182025-12-19
10889483231586Ambu900-000-624900-000-6242025-12-19
10889483231616Ambu900-000-628900-000-6282025-12-19
10889483565339BALLARD™97012970122025-12-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260217220141Oval Nooks-3G-1160-FS-O3Amtrion GmbHJAY2026-06-10
04260217222312Quick Lock-3G-912-M8-S2Amtrion GmbHJAY2026-06-10
15019517382518ICU Medical, Inc.ICU MEDICAL, INC.JAY2026-06-01
15019517382488ICU Medical, Inc.ICU MEDICAL, INC.JAY2026-04-06
15019517382495ICU Medical, Inc.ICU MEDICAL, INC.JAY2026-04-06
15019517382501ICU Medical, Inc.ICU MEDICAL, INC.JAY2026-04-06
04260217220318Circuit Support Arm ECOAmtrion GmbHJAY2026-03-30
04260217220479Vario Lock, Circuit Support Arm, 3 Joints, Bennet FootAmtrion GmbHJAY2026-03-30
20889483228576Capette™SUNMED, LLCJAY2025-12-31
10889483225462Septal-H™SUNMED, LLCJAY2025-12-16
20889483225469Septal-H™SUNMED, LLCJAY2025-12-16
10889483225431Septal-H™SUNMED, LLCJAY2025-12-15
10889483225448Septal-H™SUNMED, LLCJAY2025-12-15
10889483225455Septal-H™SUNMED, LLCJAY2025-12-15
10889483226506AirLife™SUNMED, LLCJAY2025-12-15
10889483226513AirLife™SUNMED, LLCJAY2025-12-15
10889483228586Capette™SUNMED, LLCJAY2025-12-15
10889483228593Capette™SUNMED, LLCJAY2025-12-15
10889483228609Strapette™SUNMED, LLCJAY2025-12-15
10889483228616Strapette™SUNMED, LLCJAY2025-12-15
10889483228623Capette™SUNMED, LLCJAY2025-12-15
10889483228630Capette™SUNMED, LLCJAY2025-12-15
10889483228647Capette™SUNMED, LLCJAY2025-12-15
10889483228654Strapette™SUNMED, LLCJAY2025-12-15
10889483228661Strapette™SUNMED, LLCJAY2025-12-15
10889483228692SavEar™ SUNMED, LLCJAY2025-12-15
10889483230244AirLife™SUNMED, LLCJAY2025-12-15
00653658009019Marpac IncMarpac, Inc.JAY2025-06-06
10850014574625PreVent Endo HolderPEPPER MEDICAL INC.JAY2025-03-26
10850014574632PreVent Endo HolderPEPPER MEDICAL INC.JAY2025-03-26