FDA.report

Cord Gas Syringes

Primary DI
00709078007323
Brand
Cord Gas Syringes
Company
WESTMED, INC.
Model
3182
Device description
Cord Gas Syringes, 1cc Syringe 22g x 1" (.7 x 25mm) Crickett 25u Balanced Heparin
Published
2019-07-31
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
00709078007323PrimaryGS10
10709078007337Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00709078007323007090780073237090780073230709078007323
1070907800733710709078007337

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
true
Sterilization required before use
false

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