FDA.report

Regard™

Primary DI
10326053118552
Brand
Regard™
Company
RESOURCE OPTIMIZATION & INNOVATION, L.L.C.
Model
ABGFLKT3CC23G-REG
Device description
Full Kit Pulset 3cc Syringe 23g x 1" Safety Tip 25u BH (ABG Kit)
Published
2022-06-30
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
10326053118552PackageGS1100In Commercial Distribution
00326053118555PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1032605311855210326053118552
00326053118555003260531185553260531185550326053118555

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
134472476
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
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

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00326053123528Regard™TLPCHCLR-REG2026-03-11
00326053123535Regard™TLPCHSTRP-REG2026-03-11
10326053117692Regard™A3PMSKUL4-REG2021-04-09
10326053117845Regard™A3SRGMSK2-REG2021-04-09
10326053117937Regard™VNYLEXMS3-REGVNYLEXMS3-REG2023-01-11
10326053117944Regard™VNYLEXMM3-REGVNYLEXMM3-REG2023-01-11
10326053117951Regard™VNYLEXML3-REGVNYLEXML3-REG2023-01-11
10326053117968Regard™VNYLEXMXL3-REGVNYLEXMXL3-REG2023-01-11
10326053117999Regard™A3SRGST4X-REG74713002021-04-20
20326053123164Regard™PVP1KIT- REG2025-08-15
10326053118026Regard™361066REG2025-06-10
10326053120777Regard™CVRBTELSXL-REGCVRBTELSXL-REG2025-02-06
10326053120784Regard™CVRBTTIEXL-REGCVRBTTIEXL-REG2025-01-28
20326053121528Regard™DBPCHILD-REG2024-12-02
20326053121535Regard™DBPSMADLT-REG2024-12-02
20326053121542Regard™DBPADLT-REG2024-12-02
20326053121559Regard™DBPADLTL-REG2024-12-02
20326053121566Regard™DBPLRGADLT-REG2024-12-02
20326053121573Regard™DBPLGADLTL-REG2024-12-02
20326053121580Regard™DBPTHIGH-REG2024-12-02

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