FDA.report

Blood Gas Sampler

Primary DI
10709078012249
Brand
Blood Gas Sampler
Company
WESTMED, INC.
Model
ABG-3603-VS
Device description
Blood Gas Sampler (Pulset 300 Syringe (No Heparin))
Published
2021-08-31
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

Related Records

Product Codes

CodeName
CBTArterial Blood Sampling Kit

Product Code Classifications

CodeDeviceSpecialtyClass
CBTArterial Blood Sampling KitAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00709078012235PrimaryGS10
10709078012249Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00709078012235007090780122357090780122350709078012235
1070907801224910709078012249

GMDN Terms

TermDefinition
Arterial blood sampling kitA collection of sterile devices intended to obtain an arterial blood specimen directly from a patient, usually for the determination of blood gas concentration. It typically includes a needle, heparinized syringe, sterile gauze/swab, bandage, rubber band, stopper, and patient identification label. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
092673953
Device count
100
DM exempt
false
Premarket exempt
true
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
false
Sterilization required before use
false

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30889483558274PulsetSUNMED, LLCCBT2023-06-30
30889483558281PulsetSUNMED, LLCCBT2023-06-30
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