Spectrum, Inc.

Primary DI
00850301007617
Brand
Spectrum, Inc.
Company
SPECTRUM, INC.
Model
DG2M-330
Catalog number
DG2M-330-100
Device description
Hydrophilic Syringe Tip Filter - DG2M-330-100, Non- Sterile
Published
2017-01-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FPBFilter, infusion line

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPBFilter, Infusion LineGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K852996000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K852996000DYNA GARD SYRINGE FILTERMicrogon, Inc.1985-09-19FPB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850301007617PackageGS1100In Commercial Distribution
00850301007600PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850301007617008503010076178503010076170850301007617
00850301007600008503010076008503010076000850301007600

GMDN Terms#

Term, Definition table
TermDefinition
Syringe filter, clinicalA sterile membrane intended to be used in a syringe or connected to a syringe (e.g., between the syringe and the needle or cannula) to sterilize, ultraclean, or clarify medicinal solutions during pharmaceutical preparation or patient injection. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(310)605-4497hchilders@spectrumlabs.com

Regulatory Flags#

DUNS number
039727656
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850301007020Wolf982-03715-000956920WOL2017-01-30
00850301007808Spectrum, Inc.987-03896-0007252002017-07-21
00855495007344Spectrum, Inc.982-03922-000ESS-69202017-07-21
00855495007351Spectrum, Inc.982-03954-001SD-1002017-07-21
00855495007368Spectrum, Inc.982-03955-000GCS-69202017-07-21
00855495007382Spectrum, Inc.982-03963-000956923LUM2017-07-21
00850301007860Spectrum, Inc.985-03651-0007403302017-02-14
00850301007877Spectrum, Inc.985-03652-0007404402017-02-14
00850301007884Spectrum, Inc.985-03666-0007604402017-02-14
00850301007891Spectrum, Inc.985-03667-0007605502017-02-14
00850301007907Spectrum, Inc.985-03668-0007606602017-02-14
00850301007914Spectrum, Inc.985-03691-0007805502017-02-14
00850301007921Spectrum, Inc.985-03692-0007806602017-02-14
00850301007938Spectrum, Inc.985-03526-0007020442017-02-14
00850301007945Spectrum, Inc.985-03527-0007030332017-02-14
00850301007952Spectrum, Inc.985-03528-0007030442017-02-14
00850301007969Spectrum, Inc.985-03529-0007040332017-02-14
00850301007976Richard WOLF985-03530-0007040442017-02-14
00850301007983Spectrum, Inc.985-03531-0007040552017-02-14
00850301007990Spectrum, Inc.985-03532-0007040662017-02-14

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Primary DI, Brand, Company table
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08426314391481GRI-BAGLABORATORIOS GRIFOLS SAFPB2021-10-26
28426314391416GRI-BAGLABORATORIOS GRIFOLS SAFPB2021-10-26
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