FDA.reportPublic FDA data

Pinestar Technology Inc

Primary DI
00850021301354
Brand
Pinestar Technology Inc
Company
PINESTAR TECHNOLOGY, INC.
Model
NMC-CASE
Device description
Pillowcase
Published
2020-07-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KMEBedding, Disposable, Medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KMEBedding, Disposable, MedicalGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850021301354PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850021301354008500213013548500213013540850021301354

GMDN Terms#

Term, Definition table
TermDefinition
Basic pillowcase, single-useA protective envelope for a pillow typically made of a thin-textile or reinforced-paper material that creates a physical barrier to soiling and cross-contamination. It does not include antimicrobial or dust mite barrier/prevention properties. This device is intended to be used by one patient for a limited time, without laundering, and then discarded (e.g., incinerated).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
037933645
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850021301415Pinestar Technology IncSC-1002020-07-24
00850021301361Pinestar Technology IncNMC-PIL2020-07-24
00850021301484Pinestar Technology Inc2155-92152021-06-16
00850021301453Pinestar Technology Inc76-8012020-09-28
00850021301460Pinestar Technology IncNMC-768012020-09-28
00850021301477Pinestar Technology IncNMC-300U2020-09-24
00850021301439Pinestar Technology IncPTI-402-AFL2020-08-19
00850021301446Pinestar Technology IncPTI-408FPC2020-08-19
00850021301422Pinestar Technology IncNMC-2652020-08-13
00850021301033Pinestar Technology IncNMC-SSY2020-07-23
00850021301101Pinestar Technology IncCMDL-1071612020-07-24
00850021301026Pinestar Technology IncNMC-SAB2020-07-23
00850021301040Pinestar Technology Inc2149-27102020-07-23
00850021301057Pinestar Technology Inc2155-27102020-07-23
00850021301064Pinestar Technology Inc5200-35632020-07-23
00850021301071Pinestar Technology IncCLR-8052020-07-23
00850021301088Pinestar Technology IncCLR-8072020-07-23
00850021301095Pinestar Technology IncCLR-8102020-07-23
00850021301118Pinestar Technology IncCT-HH2020-07-23
00850021301125Pinestar Technology IncDAT-HH2020-07-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840117349544Drape Sheets, Tissue / Poly 2-ply, Black, 40" x 90" (101.6 cm x 228.6 cm)Dynarex CorporationKME2026-06-08
00840117349568Pillow Cases, Tissue / Poly 2-ply, Black, 21" x 30" (53.3 cm x 76.2 cm)Dynarex CorporationKME2026-06-08
16931918119823AllesetGRI Medical & Electronic Technology Co., Ltd.KME2026-06-04
00199536911109BluelineTransparent Supply Solutions Ltd.KME2026-05-15
00199536911116BluelineTransparent Supply Solutions Ltd.KME2026-05-15
00199536911123BluelineTransparent Supply Solutions Ltd.KME2026-05-15
00199536911130BluelineTransparent Supply Solutions Ltd.KME2026-05-15
00199536911147BluelineTransparent Supply Solutions Ltd.KME2026-05-15
00199536911154BluelineTransparent Supply Solutions Ltd.KME2026-05-15
00199536911161BluelineTransparent Supply Solutions Ltd.KME2026-05-15
10304040196660Henry ScheinHENRY SCHEIN, INC.KME2026-04-17
10304040196677Henry ScheinHENRY SCHEIN, INC.KME2026-04-17
10304040196684Henry ScheinHENRY SCHEIN, INC.KME2026-04-17
10304040196691Henry ScheinHENRY SCHEIN, INC.KME2026-04-17
10304040196707Henry ScheinHENRY SCHEIN, INC.KME2026-04-17
10304040196714Henry ScheinHENRY SCHEIN, INC.KME2026-04-17
16931918105475AllesetGRI Medical & Electronic Technology Co., Ltd.KME2026-03-18
07613327632842Sage Multi-Position MATS 2.0SAGE PRODUCTS, LLCKME2025-11-19
07613327672718Sage Multi-Position MATS 2.0SAGE PRODUCTS, LLCKME2025-11-19
M68959120030Hypothermia Management SetSafeguard US Operating, LLCKME2025-10-24
10304040193157Henry ScheinHENRY SCHEIN, INC.KME2025-09-03
16931918129815HALYARDGRI Medical & Electronic Technology Co., Ltd.KME2025-06-20
10889483602911AirLife™AirLife Finland OyKME2025-04-17
10889483602928AirLife™AirLife Finland OyKME2025-04-17
10889483602935AirLife™AirLife Finland OyKME2025-04-17
10889483602942AirLife™AirLife Finland OyKME2025-04-17
10889483603031AirLife™AirLife Finland OyKME2025-04-17
10889483603048AirLife™AirLife Finland OyKME2025-04-17
10603354120669ComfortTopEHOB INCKME2025-01-22
M68959320040HAWK Advanced Hypothermia Management SetSafeguard US Operating, LLCKME2024-10-08