Regard™

Primary DI
00326053118609
Brand
Regard™
Company
RESOURCE OPTIMIZATION & INNOVATION, L.L.C.
Model
ABG3CC23G-REG
Device description
Pulset 3CC syringe 23G X 1" (0.6 X 25 MM) Safety Tip 25U BH (ABG)
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

Product Codes#

Code, Name table
CodeName
CBTArterial Blood Sampling Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CBTArterial Blood Sampling KitAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00326053118609PrimaryGS10
10326053118606Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00326053118609003260531186093260531186090326053118609
1032605311860610326053118606

GMDN Terms#

Term, Definition table
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 table
Method

Regulatory Flags#

DUNS number
134472476
Device count
100
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 DI, Brand, Model table
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00653160386677MEDLINEMEDLINE INDUSTRIES, INC.CBT2025-03-10
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30889483613102A-LineSUNMED, LLCCBT2024-05-17
30889483613119A-LineSUNMED, LLCCBT2024-05-17
30889483613126PulsetSUNMED, LLCCBT2024-05-17
30889483479401Atellica® VTR SyringesSUNMED, LLCCBT2023-06-30
30889483479418Atellica® VTR SyringesSUNMED, LLCCBT2023-06-30
30889483479463Atellica® VTR SyringesSUNMED, LLCCBT2023-06-30
30889483479470Atellica® VTR SyringesSUNMED, LLCCBT2023-06-30
30889483479487Atellica® VTR SyringesSUNMED, LLCCBT2023-06-30
30889483479494Atellica® VTR SyringesSUNMED, LLCCBT2023-06-30
30889483479500Atellica® VTR SyringesSUNMED, LLCCBT2023-06-30
30889483558243Pulset SUNMED, LLCCBT2023-06-30
30889483558250PulsetSUNMED, LLCCBT2023-06-30
30889483558267PulsetSUNMED, LLCCBT2023-06-30
30889483558274PulsetSUNMED, LLCCBT2023-06-30
30889483558281PulsetSUNMED, LLCCBT2023-06-30
30889483558298PulsetSUNMED, LLCCBT2023-06-30
30889483558304PulsetSUNMED, LLCCBT2023-06-30
30889483558311PulsetSUNMED, LLCCBT2023-06-30
10889483558324PulsetSUNMED, LLCCBT2023-06-30
30889483558335PulsetSUNMED, LLCCBT2023-06-30
04015630036684Roche MICROSAMPLER PROTECTRoche Diagnostics GmbHCBT2023-04-24
06976025820012HupaiJiangsu Chongheng Medical Technology Co., Ltd.CBT2023-03-08
00653160356670MEDLINEMEDLINE INDUSTRIES, INC.CBT2022-11-08
00653160355765MEDLINEMEDLINE INDUSTRIES, INC.CBT2022-10-17
00653160355475MEDLINEMEDLINE INDUSTRIES, INC.CBT2022-09-27
00653160355147CenturionCENTURION MEDICAL PRODUCTS CORPORATIONCBT2022-09-03
00653160355192MEDLINEMEDLINE INDUSTRIES, INC.CBT2022-09-03