FDA.report

SOL-M™ Multi-Sample Needle

Primary DI
10818392015406
Brand
SOL-M™ Multi-Sample Needle
Company
SOL-MILLENNIUM MEDICAL INC
Model
110201020004
Device description
SOL-M™ Multi-Sample Needle 21G*1”
Published
2018-07-03
Public version status
Update
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

Contact Domains

Product Codes

CodeName
JKATubes, vials, systems, serum separators, blood collection

Product Code Classifications

CodeDeviceSpecialtyClass
JKATubes, Vials, Systems, Serum Separators, Blood CollectionClinical Chemistry2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10818392015406PackageGS1100In Commercial Distribution
20818392015403PackageGS110In Commercial Distribution
00818392015409PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1081839201540610818392015406
2081839201540320818392015403
00818392015409008183920154098183920154090818392015409

GMDN Terms

TermDefinition
Blood collection needleA sterile, sharp bevel-edged, hollow tubular metal instrument intended to be used as part of a blood collection set for drawing blood from a patient. It is intended to be connected to blood collection tubing and/or a blood collection Luer connector for transfer into a blood specimen receptacle. It may include a pre-attached blood collection tube spike however it does not include a blood collection tube holder. This is a single-use device.

Device Sizes

TypeValueUnit
Length25Millimeter
Needle Gauge21Gauge

Sterilization Methods

Method

Contacts

PhoneEmail
+1(404)973-2200SOLMCHUinform@sol-m.com
833-637-0857info@solm.com

Regulatory Flags

DUNS number
069590113
Device count
1
DM exempt
false
Premarket exempt
false
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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20818392014680SOL-CARE Safety Multi-Sample Needle SMSN221252019-10-16
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20818392014970SOL-CARE Safety Multi-Sample Needle with Pre-attached Holder SMSNH221252019-10-16
20818392018596SOL-CARE Safety NeedlePSN21102019-04-12
10818392018612SOL-CARE Safety NeedlePSN22102019-04-12
20818392018749SOL-CARE Safety NeedlePSN30122019-04-12
10818392018452SOL-CARE Safety NeedlePSN18152019-04-10
10818392018537SOL-CARE Safety NeedlePSN22152019-04-10
10818392018568SOL-CARE Safety NeedlePSN25152019-04-10
10818392018629SOL-CARE Safety NeedlePSN23102019-04-10
20818392018664SOL-CARE Safety NeedlePSN25582019-04-10
20818392018671SOL-CARE Safety NeedlePSN25102019-04-10
10818392018728SOL-CARE Safety NeedlePSN27122019-04-10
10818392010401SOL-CARE™ Safety NeedleSN30122016-09-16
10818392010432SOL-CARE™ Safety NeedleSN27582016-09-16

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