FDA.reportPublic FDA data

Vital Signs™

Primary DI
10889483560938
Brand
Vital Signs™
Company
SUNMED, LLC
Model
5620004
Catalog number
5620004
Device description
Vital Signs™ Sub-Assembly 1/2 L Latex Free Breathing Bag, Bleed Tail Valve
Published
2025-12-19
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
BTCBag, Reservoir

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTCBag, ReservoirAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20889483560935PackageGS1300In Commercial Distribution
10889483560938PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088948356093520889483560935
1088948356093810889483560938

GMDN Terms#

Term, Definition table
TermDefinition
Breathing circuit bag, reusableA non-sterile elastomeric reservoir sac intended to store breathing gas during the respiratory cycle. The breathing bag may be on the inspiratory or expiratory limb of a breathing circuit depending on the breathing circuit design. It may also function as a maximum pressure limiting device during spontaneous or manually assisted ventilation. It may be made of conductive or non-conductive material and is typically used in anaesthesia or ventilator breathing circuits. This is a reusable 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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10889483054321AirLife™048004802025-12-18
10889483054338AirLife™079507952025-12-19
10889483229422AirLife™048504852025-12-19
10889483564288BALLARD™22103-522103-52025-11-20
10889483564394BALLARD™22113-522113-52025-11-21
10889483564608BALLARD™227101322710132025-11-24
10889483564646BALLARD™22712183227121832025-11-24
10889483564806BALLARD™2271603-52271603-52025-11-21
10889483564813BALLARD™22716036-522716036-52025-11-21
10889483564905BALLARD™227166-5227166-52025-11-21
10889483564936BALLARD™2276-52276-52025-11-21
10889483567005BALLARD™2271652271652025-11-24
10889483623411BALLARD™22056-522056-52025-11-20
10889483623541BALLARD™2271516-52271516-52025-11-21
10889483562611BALLARD™227-5227-52025-11-21
10889483564370BALLARD™22108-522108-52025-11-21
10889483564424BALLARD™2255-52255-52025-11-21
10889483564479BALLARD™2260-52260-52025-11-21
10889483564486BALLARD™22606-522606-52025-11-21
10889483564554BALLARD™22703-522703-52025-11-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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04719874950781Create BiotechCREATE BIOTECH CO., LTD.BTC2026-07-21
04719874952440Create BiotechCREATE BIOTECH CO., LTD.BTC2026-07-21
04816415501430BREATHING BAG single use 500ASSOMEDIKA, OOOBTC2026-05-27
04816415501447BREATHING BAG single use 1000ASSOMEDIKA, OOOBTC2026-05-27
04816415501454BREATHING BAG single use 2000ASSOMEDIKA, OOOBTC2026-05-27
04816415501461BREATHING BAG single use 3000ASSOMEDIKA, OOOBTC2026-05-27
04816415501478BREATHING BAG reusable 500ASSOMEDIKA, OOOBTC2026-05-27
04816415501485BREATHING BAG reusable 1000ASSOMEDIKA, OOOBTC2026-05-27
04816415501492BREATHING BAG reusable 2000ASSOMEDIKA, OOOBTC2026-05-27
04816415501508BREATHING BAG reusable 3000ASSOMEDIKA, OOOBTC2026-05-27
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