FDA.reportPublic FDA data

Pulset™ 1cc Syringe

Primary DI
10709078004626
Brand
Pulset™ 1cc Syringe
Company
WESTMED, INC.
Model
3100
Device description
Pulset™ 1cc Syringe, Minikit, No Needle, ~15u Balanced Heparin
Published
2021-04-28
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
00709078004612PrimaryGS10
10709078004626Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00709078004612007090780046127090780046120709078004612
1070907800462610709078004626

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
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00709078000515Nebulizer02232016-11-24
00709078000560Nebulizer03252016-11-24
00709078000614Nebulizer02052016-11-24
00709078006197VixOne Nebulizer02332018-11-30
20889483528614AMBU Hyperinflation System900 000 6142026-03-05
20889483528737AMBU Hyperinflation System900 000 6172026-03-05
20889483528751AMBU Hyperinflation System900 000 6182026-03-05
20889483528867AMBU Hyperinflation System900 000 6242026-03-05
20889483528942AMBU Hyperinflation System900 000 6282026-03-05
20889483568795AMBU Hyperinflation System900 000 6012026-03-05
20889483542801AMBU Hyperinflation System900 000 6022026-03-05
20889483542849AMBU Hyperinflation System900 000 6042026-03-05
20889483542863AMBU Hyperinflation System900 000 6052026-03-05
20889483542887AMBU Hyperinflation System900 000 6062026-03-05
20889483542924AMBU Hyperinflation System900 000 6092026-03-05
20889483542962AMBU Hyperinflation System900 000 6112026-03-05
10709078000574VixOneVOID 02482025-11-24
00709078049996FilterVoid OU812b2025-09-23
00709078050008FilterVoid OU812a2025-09-23
10709078008402Flex Extenders7-51322024-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00653160386677MEDLINEMEDLINE INDUSTRIES, INC.CBT2025-03-10
10889483581995AirLife™Sunmed Group Holdings, LLCCBT2024-12-12
30889483613096A-LineSUNMED, LLCCBT2024-05-17
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