FDA.reportPublic FDA data

GaleMed

Primary DI
04710810082030
Brand
GaleMed
Company
GaleMed Xiamen Co., Ltd.
Model
70062
Device description
Disposable Tube Clip 22mm
Published
2015-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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
44710810082038PackageGS120In Commercial Distribution
04710810082030PrimaryGS10
94710810082033Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
4471081008203844710810082038
04710810082030047108100820304710810082030
9471081008203394710810082033

GMDN Terms#

Term, Definition table
TermDefinition
Universal patient tubing holder, non-sterileA small, non-sterile device with a locking/holding mechanism designed to secure tubing or tubing-like devices (e.g., cables, cords) to a patient or to a surgical drape during a clinical intervention. It is typically designed as: 1) an adhesive pad (plaster), strip, or bandage intended to attach to the patient's skin or drape with the exposed side having an integrated fixation mechanism (e.g., Velcro hook/loop closure); or 2) a mechanical closure or gripping system intended to hold the tubing or tubing hub in place. It is not designed to hold a specific type or brand of tubing. This is a single-patient device that may be reapplied over a short term (single-use) before being discarded.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-40 Degrees Celsius60 Degrees Celsius

Regulatory Flags#

DUNS number
527333326
Device count
100
Premarket exempt
true
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
06923980111907MindrayXMR00512026-05-26
06923980112546MindrayXMR00662026-05-26
06923980112577MindrayXMR00242026-05-26
06923980112584MindrayXMR00262026-05-26
06923980112591MindrayXMR01012026-05-26
06923980112607MindrayXMR01022026-05-26
06923980112614MindrayXMR00522026-05-26
06923980112621MindrayXMR00532026-05-26
06923980112638MindrayXMR00812026-05-26
06923980112690MindrayXMR01042026-05-26
06923980112799MindrayXMR00582026-05-26
06923980112805MindrayXMR00442026-05-26
06923980112829MindrayXMR00462026-05-26
06944904007236MindrayXMR00862026-05-26
16923980111843MindrayXMR02302026-05-26
06923980112522MindrayXMR00112026-05-25
06923980112539MindrayXMR00122026-05-25
06923980112553MindrayXMR00212026-05-25
06923980112560MindrayXMR00232026-05-25
06923980112645MindrayXMR00152026-05-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10889483228579Capette™SUNMED, LLCJAY2025-12-31
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
00850014574604PreVent Endo HolderPEPPER MEDICAL INC.JAY2025-03-26